May 29, 2013 07:15 CET
Novartis highlights new findings in advancing care for patients with 170 abstracts in breast, lung and blood cancers at ASCO and EHA
- Latest Phase III research on Afinitor® in HER2 positive advanced breast cancer
- JakaviTM overall survival advantage evaluated in three-year study in patients with myelofibrosis, a rare and life-threatening blood cancer
- Multi-year studies evaluating deep molecular response with Tasigna® in patients with Ph+CML
- Data from LDK378 trial in ALK+ metastatic non-small cell lung cancer; supports recent FDA Breakthrough Therapy designation
Basel, May 29, 2013 - Novartis will present new findings in the treatment of advanced cancers and other diseases with 170 abstracts at two prominent medical meetings. Research across the extensive Novartis product portfolio and pipeline showcases the progress in advancing care for patients with cancer and hematological diseases.
Clinical data from multiple compounds will be featured at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) including Afinitor® (everolimus), Tasigna® (nilotinib) and the pipeline compound LDK378[1]. The 18th Congress of the European Hematology Association (EHA) will showcase data from JakaviTM (ruxolitinib), Tasigna and Exjade® (deferasirox)[2].
"With a pipeline of more than 25 new molecular entities, we are at the forefront of a new era in oncology drug development, working towards advances for cancer patients," said Hervé Hoppenot, President, Novartis Oncology. "These data demonstrate our progress in furthering research and development through a highly-targeted approach, matching specific compounds to pathways that are involved in many difficult-to-treat cancers."
Data highlights include:
Studies examining Afinitorin advanced breast cancer at ASCO
- BOLERO-3 study evaluating potential safety and efficacy of Afinitor in combination with trastuzumab and vinorelbine in women with HER2 positive advanced breast cancer who are resistant to trastuzumab and have been pre-treated with a taxane (abstract #505; June 2, 9:15 AM)
- Updates on Afinitor in hormone receptor-positive (HR+) advanced breast cancer, including BOLERO-2 sub-analyses (abstract #553, abstract #557, abstract #558, abstract #561; June 1, 1:15 PM) and a late-breaker examining genetic variations and their potential correlation with benefit (abstract #LBA509; June 3, 1:15 PM)
Survival data from Jakaviin myelofibrosis and analysis on bone marrow fibrosis
- At EHA: Three-year data evaluating overall survival advantage, as well as impact on spleen volume and safety from the Jakavi Phase III COMFORT-II clinical trial program (abstract #S1111; June 16, 8:00 AM)
- At ASCO and EHA: First evidence of the effect of Jakavi on bone marrow fibrosis in myelofibrosis patients at 24 and 48 months from a Phase I/II trial (ASCO abstract #7030; June 4, 8:30 AM; EHA abstract #S591; June 15, 4:15 PM)
Multi-year studies of Tasigna in patients with Ph+ CML
- At ASCO and EHA: Two-year follow-up results from the ENESTcmr study evaluating sustained deep molecular response following a switch to Tasigna in patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase who still had evidence of residual disease after two or more years of Glivec®(imatinib)* therapy (ASCO abstract #7053; June 2, 8:00 AM; EHA abstract #P133; June 14, 5:45 PM)
- At ASCO and EHA: Four-year update from the ENESTnd study evaluating molecular response rates of Tasigna compared to Glivec in patients with newly diagnosed Ph+ CML in chronic phase (ASCO abstract #7052; June 2, 8:00 AM; EHA abstract #P712; June 15, 5:45 PM)
- At ASCO: ENESTnd landmark data correlating early molecular responses in patients with newly diagnosed Ph+ CML in chronic phase with long-term outcomes (abstract #7054; June 2, 8:00 AM)
- At EHA: Phase II GIMEMA study evaluating the sustainability of deep molecular response at five years in patients treated frontline with Tasigna (abstract #P141; June 14, 5:45 PM)
Survival data from PROMID study of Sandostatin® LAR® in NET at ASCO
- Follow-up analysis from the PROMID trial evaluating overall survival in patients with metastatic midgut neuroendocrine tumors (NET) taking Sandostatin LAR Depot (octreotide acetate for injectable suspension) vs. placebo (ASCO abstract #4030; June 3, 1:15 PM)
First-in-human study of LDK378 in ALK+ metastatic NSCLC at ASCO
- Updated data from the first-in-human Phase I trial of LDK378, a selective inhibitor of the cancer target anaplastic lymphoma kinase (ALK), in patients with ALK+ metastatic non-small cell lung cancer (abstract #8010; June 3, 10:15 AM). In March, the US Food and Drug Administration (FDA) granted LDK378 Breakthrough Therapy designation, a status intended to expedite the development and review of drugs that treat serious or life-threatening conditions
Multi-year analysis of iron overload association with morbidity risk in untreated thalassemia intermedia patients at EHA
- Analysis of association between iron overload and morbidity risk in patients with thalassemia intermedia, a form of non-transfusion-dependent thalassemia (NTDT), over an 11-year period. This retrospective study examined 52 patients with no history of transfusion or iron chelation, from comprehensive care centers in Italy, Lebanon, Oman, Iran and Egypt (abstract #S1172; June 16, 10:30 AM)
Additional pipeline research in melanoma, breast cancer and solid tumors at ASCO
- Initial results from a Phase I study of LGX818 in patients with BRAF V600 mutant advanced or metastatic melanoma (abstract #9028; June 3, 8:00 AM)
- Preliminary results from a Phase Ib/II open-label, dose-escalation study of LGX818 + MEK162** in BRAF V600-dependent advanced solid tumors (abstract #9029; June 3, 8:00 AM)
- Results from the first in-human study of the PI3K inhibitor BYL719 in patients with PIK3CA mutant ER-positive metastatic breast cancer (abstract #2531; June 4, 8:00 AM)
About Afinitor (everolimus)
Everolimus is approved as Afinitor® in the European Union (EU) for the treatment of hormone receptor-positive, HER2 negative (HR+/HER2 negative) advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. In the United States (US), Afinitor is approved for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2 negative breast cancer (advanced HR+/HER2 negative) in combination with exemestane after failure of treatment with letrozole or anastrozole.
Everolimus is approved as Afinitor® in the European Union (EU) for the treatment of hormone receptor-positive, HER2 negative (HR+/HER2 negative) advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. In the United States (US), Afinitor is approved for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2 negative breast cancer (advanced HR+/HER2 negative) in combination with exemestane after failure of treatment with letrozole or anastrozole.
Afinitor® (everolimus) tablets is approved in more than 95 countries including the US and throughout the EU in the oncology settings of advanced renal cell carcinoma (RCC) following progression on or after vascular endothelial growth factor (VEGF)-targeted therapy, and in the US and EU for locally advanced, metastatic or unresectable progressive neuroendocrine tumors of pancreatic origin (pNET).
Everolimus is also approved as Votubia® (everolimus) tablets in the EU for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumor size or presence of aneurysm, or presence of multiple or bilateral tumors) but who do not require immediate surgery. The evidence is based on analysis of change in sum of angiomyolipoma volume. Votubia is also approved in the EU for the treatment of patients aged 3 years and older with subependymal giant cell astrocytoma (SEGA) associated with TSC, who require therapeutic intervention but are not amenable to surgery. The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease-related symptoms, has not been demonstrated.
Everolimus is also available from Novartis for use in certain non-oncology patient populations under the brand names Certican® and Zortress® and is exclusively licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents.
Indications vary by country and not all indications are available in every country. The safety and efficacy profile of everolimus has not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that everolimus will become commercially available for additional indications anywhere else in the world.
Afinitor Important Safety Information
Afinitor/Votubia can cause serious side effects including lung or breathing problems, infections (including sepsis), and kidney failure, which can lead to death. Mouth ulcers and mouth sores are common side effects. Afinitor/Votubia can affect blood cell counts, kidney and liver function, and blood sugar, cholesterol, and triglyceride levels. Afinitor/Votubia may cause fetal harm in pregnant women. Highly effective contraception is recommended for women of child-bearing potential while receiving Afinitor/Votubia and for up to eight weeks after ending treatment. Women taking Afinitor/Votubia should not breast feed. Fertility in women and men may be affected by treatment with Afinitor/Votubia.
Afinitor/Votubia can cause serious side effects including lung or breathing problems, infections (including sepsis), and kidney failure, which can lead to death. Mouth ulcers and mouth sores are common side effects. Afinitor/Votubia can affect blood cell counts, kidney and liver function, and blood sugar, cholesterol, and triglyceride levels. Afinitor/Votubia may cause fetal harm in pregnant women. Highly effective contraception is recommended for women of child-bearing potential while receiving Afinitor/Votubia and for up to eight weeks after ending treatment. Women taking Afinitor/Votubia should not breast feed. Fertility in women and men may be affected by treatment with Afinitor/Votubia.
The most common adverse drug reactions (incidence >=10 percent) are mouth ulcers, skin rash, feeling tired or weak, diarrhea, nausea, decreased appetite, infections (including upper respiratory tract infection, low level of red blood cells, abnormal taste, inflammation of lung tissue, weight loss, swelling of extremities or other parts of the body, nose bleeds, itching, vomiting, high level of blood cholesterol, headache, high level of blood sugar, cough, spontaneous bleeding or bruising, and breathlessness. The most common Grade 3-4 adverse drug reactions (incidence >=2 percent) are mouth ulcers, feeling tired or weak, infections, inflammation of lung tissue, diarrhea, spontaneous bleeding or bruising, low white blood cells (a type of blood cell that fights infection), and breathlessness. Cases of hepatitis B reactivation, blood clots in the lung or legs, and menstruation disorders such as absence of periods have been reported. Abnormalities were observed in hematology and clinical chemistry laboratory tests.
Please see full Prescribing Information available at www.afinitor.com.
About Jakavi (ruxolitinib)
Jakavi® (ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases and was approved by the European Commission in August 2012 for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. Jakavi is approved in more than 35 countries, including the member states of the European Union, Canada and some countries in Asia, Latin and South America. Additional worldwide regulatory filings are underway.
Jakavi® (ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases and was approved by the European Commission in August 2012 for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. Jakavi is approved in more than 35 countries, including the member states of the European Union, Canada and some countries in Asia, Latin and South America. Additional worldwide regulatory filings are underway.
Novartis licensed ruxolitinib from Incyte Corporation for development and commercialization outside the United States. Both the European Commission and the US Food and Drug Administration (FDA) granted ruxolitinib orphan drug status for myelofibrosis. Jakavi is marketed in the United States by Incyte Corporation under the name Jakafi® for the treatment of patients with intermediate or high-risk myelofibrosis.
The recommended starting dose for Jakavi is 15 mg twice daily for patients with a platelet count between 100,000cubic millimeters (mm3) and 200,000 mm3,and 20 mg twice daily for patients with a platelet count of >200,000 mm3. Doses may be titrated based on safety and efficacy. There is limited information to recommend a starting dose for patients with platelet counts between 50,000/mm3 and <100,000/mm3. The maximum recommended starting dose in these patients is 5 mg twice daily and patients should be titrated cautiously.
Jakavi is a registered trademark of Novartis AG in countries outside the United States. Jakafi is a registered trademark of Incyte Corporation.
Jakavi Important Safety Information
Jakavi® can cause serious side effects, including a decrease in blood cell count and infections. Complete blood count monitoring is recommended. Dose reduction or interruption may be required in patients with severe hepatic or renal impairment or in patients developing hematologic adverse reactions such as thrombocytopenia, anemia and neutropenia. Dose reductions are also recommended when Jakavi is co-administered with strong CYP3A4 inhibitors or fluconazole. Use of Jakavi during pregnancy is not recommended and women should avoid becoming pregnant during Jakavi therapy. Women taking Jakavi should not breast feed.
Jakavi® can cause serious side effects, including a decrease in blood cell count and infections. Complete blood count monitoring is recommended. Dose reduction or interruption may be required in patients with severe hepatic or renal impairment or in patients developing hematologic adverse reactions such as thrombocytopenia, anemia and neutropenia. Dose reductions are also recommended when Jakavi is co-administered with strong CYP3A4 inhibitors or fluconazole. Use of Jakavi during pregnancy is not recommended and women should avoid becoming pregnant during Jakavi therapy. Women taking Jakavi should not breast feed.
The most common adverse drug reactions, occurring at any level of severity (incidence >10%) are urinary tract infections, anemia, thrombocytopenia, neutropenia, hypercholesterolemia, dizziness, headache, alanine aminotransaminase increased, asparte aminotransferase increased, bruising, bleeding and increased blood pressure. Other common adverse drug reactions (incidence 1 to 10%) are herpes zoster, weight gain, flatulence and tuberculosis (1%). Progressive multifocal leukencephalopathy (PML) has been reported. Physicians should be alert for neuropsychiatric symptoms suggestive of PML.
Please see full Prescribing Information available at www.jakavi.com.
About Tasigna (nilotinib)
Tasigna® (nilotinib) is approved in more than 90 countries for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) in adult patients resistant or intolerant to at least one prior therapy, including Glivec, and for the treatment of adult patients with newly diagnosed Ph+ CML in chronic phase. Take twice daily 12 hours apart. Do not take with food. No food to be consumed for 2 hours before or one hour after dosing. Avoid grapefruit juice and CYP3A4 inhibitors.
Tasigna® (nilotinib) is approved in more than 90 countries for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) in adult patients resistant or intolerant to at least one prior therapy, including Glivec, and for the treatment of adult patients with newly diagnosed Ph+ CML in chronic phase. Take twice daily 12 hours apart. Do not take with food. No food to be consumed for 2 hours before or one hour after dosing. Avoid grapefruit juice and CYP3A4 inhibitors.
Tasigna Important Safety Information
Use with caution in patients with uncontrolled or significant cardiac disease and in patients who have or may develop prolongation of QTc. Low levels of potassium or magnesium must be corrected prior to Tasigna administration. Monitor closely for an effect on the QTc interval. Baseline ECG is recommended prior to initiating therapy and as clinically indicated. Uncommon cases (0.1 to 1%) of sudden death have been reported in clinical studies in patients with significant risk factors.
Use with caution in patients with uncontrolled or significant cardiac disease and in patients who have or may develop prolongation of QTc. Low levels of potassium or magnesium must be corrected prior to Tasigna administration. Monitor closely for an effect on the QTc interval. Baseline ECG is recommended prior to initiating therapy and as clinically indicated. Uncommon cases (0.1 to 1%) of sudden death have been reported in clinical studies in patients with significant risk factors.
Use with caution in patients with liver impairment, with a history of pancreatitis and with total gastrectomy. Patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption should not use Tasigna. Tasigna may cause fetal harm in pregnant women. Women taking Tasigna should not breastfeed.
The most frequent Grade 3 or 4 adverse events are hematological (neutropenia and thrombocytopenia) which are generally reversible and usually managed by withholding Tasigna temporarily or dose reduction. Monitor blood counts regularly. Pancreatitis has been reported. The most frequent non-hematologic adverse events were rash, pruritus, nausea, fatigue, headache, alopecia, myalgia, constipation and diarrhea. Most of these adverse events were mild to moderate in severity.
Please see full Prescribing Information available at www.tasigna.com.
About Glivec (imatinib)
Glivec® (imatinib) is approved in more than 110 countries for the treatment of all phases of Ph+ CML, for the treatment of adult patients with KIT (CD117)-positive gastrointestinal stromal tumors (GIST), which cannot be surgically removed and/or have metastasized and for the treatment of adult patients following complete surgical removal of KIT+ GIST. Take with food and a large glass of water.
Glivec® (imatinib) is approved in more than 110 countries for the treatment of all phases of Ph+ CML, for the treatment of adult patients with KIT (CD117)-positive gastrointestinal stromal tumors (GIST), which cannot be surgically removed and/or have metastasized and for the treatment of adult patients following complete surgical removal of KIT+ GIST. Take with food and a large glass of water.
Glivec Important Safety Information
Glivec can cause fetal harm in pregnant woman. Glivec has been associated with severe edema (swelling) and serious fluid retention. Cytopenias (anemia, neutropenia, thrombocytopenia) are common, generally reversible and usually managed by withholding Glivec or dose reduction. Monitor blood counts regularly. Severe congestive heart failure and left ventricle dysfunction, severe liver problems including cases of fatal liver failure and severe liver injury requiring liver transplants have been reported. Use caution in patients with cardiac dysfunction and hepatic dysfunction. Monitor carefully.
Glivec can cause fetal harm in pregnant woman. Glivec has been associated with severe edema (swelling) and serious fluid retention. Cytopenias (anemia, neutropenia, thrombocytopenia) are common, generally reversible and usually managed by withholding Glivec or dose reduction. Monitor blood counts regularly. Severe congestive heart failure and left ventricle dysfunction, severe liver problems including cases of fatal liver failure and severe liver injury requiring liver transplants have been reported. Use caution in patients with cardiac dysfunction and hepatic dysfunction. Monitor carefully.
Bleeding may occur. Severe gastrointestinal (GI) bleeding has been reported in patients with KIT+ GIST. Skin reactions, hypothyroidism in patients taking levothyroxine replacement, GI perforation, in some cases fatal and tumor lysis syndrome, which can be life threatening, have also been reported with Glivec. Correct dehydration and high uric acid levels prior to treatment. Long-term use may result in potential liver, kidney, and/or heart toxicities; immune system suppression may also result from long-term use. In patients with hypereosinophilic syndrome and heart involvement, cases of heart disease have been associated with the initiation of Glivec therapy. Growth retardation has been reported in children taking Glivec. The long-term effects of extended treatment with Glivec on growth in children are unknown.
The most common side effects include fluid retention, muscle cramps or pain and bone pain, abdominal pain, loss of appetite, vomiting, diarrhea, decreased hemoglobin, abnormal bleeding, nausea, fatigue and rash.
Please see full Prescribing Information available at www.glivec.com.
About Sandostatin LAR (octreotide acetate for injectable suspension)
Sandostatin® LAR® is a long-acting, injectable depot formulation of octreoide acetate that is indicated for the treatment of patients with acromegaly who are adequately controlled on s.c. treatment with Sandostatin; in patients in whom surgery or radiotherapy is inappropriate or ineffective; in the interim period until radiotherapy becomes fully effective. Relief of symptoms associated with functional gastro-entero-pancreatic endocrine tumors: carcinoid tumors with features of the carcinoid syndrome, VIPomas, glucagonomas, gastrinomas/Zollinger-Ellison syndrome, insulinomas, GRFomas. Treatment of patients with advanced neuroendocrine tumors of the midgut or unknown primary tumor location.
Sandostatin® LAR® is a long-acting, injectable depot formulation of octreoide acetate that is indicated for the treatment of patients with acromegaly who are adequately controlled on s.c. treatment with Sandostatin; in patients in whom surgery or radiotherapy is inappropriate or ineffective; in the interim period until radiotherapy becomes fully effective. Relief of symptoms associated with functional gastro-entero-pancreatic endocrine tumors: carcinoid tumors with features of the carcinoid syndrome, VIPomas, glucagonomas, gastrinomas/Zollinger-Ellison syndrome, insulinomas, GRFomas. Treatment of patients with advanced neuroendocrine tumors of the midgut or unknown primary tumor location.
Sandostatin LAR was first approved in France in June 1995 and is currently approved in 95 countries. For more than a decade, Sandostatin LAR has achieved a long-standing track record of sustained efficacy with a well-established safety profile.
Not all indications are approved in every country.
Sandostatin LAR Important Safety Information
Indication
Sandostatin LAR is indicated for:
Sandostatin LAR is indicated for:
- Treatment of patients with Acromegaly:
- who are adequately controlled on s.c. treatment with Sandostatin;
- in whom surgery or radiotherapy is inappropriate or ineffective; in the interim period until radiotherapy becomes fully effective.
- Treatment of patients with symptoms associated with functional gastro-entero-pancreatic endocrine tumors in whom symptoms are adequately controlled on s.c. treatment with Sandostatin: carcinoid tumors with features of the carcinoid syndrome, VIPomas, glucagonomas, gastrinomas/Zollinger-Ellison syndrome, insulinomas, GRFomas.
- Treatment of patients with advanced neuroendocrine tumors of the midgut or unknown primary tumor location.
Contraindications
Known hypersensitivity to octreotide or to any of the excipients
Known hypersensitivity to octreotide or to any of the excipients
Warnings and Precautions
Uncommon cases of bradycardia have been reported. Dose adjustments of drugs such as beta-blockers, calcium channel blockers, or agents to control fluid and electrolyte balance, may be necessary.
Uncommon cases of bradycardia have been reported. Dose adjustments of drugs such as beta-blockers, calcium channel blockers, or agents to control fluid and electrolyte balance, may be necessary.
Gallbladder abnormalities may occur. Patients should be monitored periodically.
Hypoglycemia or hyperglycemia may occur. Blood glucose levels should be monitored when treatment is initiated or when the dose is altered. Antidiabetic treatment should be adjusted accordingly. Caution in patients with insulinomas or diabetes mellitus. These patients should be monitored closely.
Octreotide may alter absorption of dietary fats in some patients. Monitoring of vitamin B12 levels is recommended in patients with a history of vitamin B12 deprivation.
Hypothyroidism may occur. Thyroid function should be monitored in patients receiving prolonged treatment with octreotide.
Caution in females of child-bearing potential. Patients should be advised to use adequate contraception. Use in pregnant women only under compelling circumstances. Do not breast-feed during treatment.
Drug Interactions
Monitoring and possible dose adjustment may be required when used with cyclosporine, cimetidine or bromocriptine. Drugs mainly metabolized by CYP3A4 and which have a low therapeutic index should be used with caution.
Monitoring and possible dose adjustment may be required when used with cyclosporine, cimetidine or bromocriptine. Drugs mainly metabolized by CYP3A4 and which have a low therapeutic index should be used with caution.
Adverse Events
The most commonly reported adverse reactions in clinical trials were diarrhea, abdominal pain, nausea, flatulence headache, cholelithiasis, hyperglycemia and constipation. Other commonly reported adverse reactions were dizziness, localized pain, biliary sludge, thyroid dysfunction (e.g., decreased thyroid stimulating hormone [TSH], decreased Total T4, and decreased Free T4), loose stools, impaired glucose tolerance, vomiting, asthenia, and hypoglycemia. In rare instances, gastrointestinal side effects may resemble acute intestinal obstruction, with progressive abdominal distension, severe epigastric pain, abdominal tenderness and guarding. In very rare instances, acute pancreatitis has been reported within the first hours or days of treatment and resolved on withdrawal of the drug. Cholelithiasis-induced pancreatitis has been reported on long-term treatment.
The most commonly reported adverse reactions in clinical trials were diarrhea, abdominal pain, nausea, flatulence headache, cholelithiasis, hyperglycemia and constipation. Other commonly reported adverse reactions were dizziness, localized pain, biliary sludge, thyroid dysfunction (e.g., decreased thyroid stimulating hormone [TSH], decreased Total T4, and decreased Free T4), loose stools, impaired glucose tolerance, vomiting, asthenia, and hypoglycemia. In rare instances, gastrointestinal side effects may resemble acute intestinal obstruction, with progressive abdominal distension, severe epigastric pain, abdominal tenderness and guarding. In very rare instances, acute pancreatitis has been reported within the first hours or days of treatment and resolved on withdrawal of the drug. Cholelithiasis-induced pancreatitis has been reported on long-term treatment.
Post-marketing adverse reactions include: anaphylaxis, allergy/hypersensitivity reactions, urticaria, acute pancreatitis, acute hepatitis without cholestasis, cholestatic hepatitis, cholestasis, jaundice, cholestatic jaundice, arrhythmia, increased alkaline phosphatase levels, and increased gamma glutamyl transferase levels.
Please see full Prescribing Information for Sandostatin LAR Depot.
About Exjade (deferasirox)
Exjade is an oral iron chelation therapy indicated for the treatment of chronic iron overload due to frequent blood transfusions (>=7 ml/kg/month of packed red blood cells) in patients with beta-thalassemia aged 6 years and older). It is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: patients with beta-thalassemia major with iron overload due to frequent blood transfusions (>=7 ml/kg/month of packed red blood cells) aged 2 to 5 years; patients with beta-thalassemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older; and patients with other anemias aged 2 years and older. Exjade is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassemia syndromes aged 10 years and older.
Exjade is an oral iron chelation therapy indicated for the treatment of chronic iron overload due to frequent blood transfusions (>=7 ml/kg/month of packed red blood cells) in patients with beta-thalassemia aged 6 years and older). It is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: patients with beta-thalassemia major with iron overload due to frequent blood transfusions (>=7 ml/kg/month of packed red blood cells) aged 2 to 5 years; patients with beta-thalassemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older; and patients with other anemias aged 2 years and older. Exjade is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassemia syndromes aged 10 years and older.
It is approved in more than 100 countries including the US, Switzerland, Japan and countries comprising the EU. The approved indication may vary depending upon the individual country.
Exjade Important Safety Information
Exjade is contraindicated in patients with an estimated creatinine clearance <60 mL/min, with hypersensitivity to the active substance or any of the excipients, or in combination with other iron chelator therapies. Exjade is not recommended in patients with severe hepatic impairment.
Exjade is contraindicated in patients with an estimated creatinine clearance <60 mL/min, with hypersensitivity to the active substance or any of the excipients, or in combination with other iron chelator therapies. Exjade is not recommended in patients with severe hepatic impairment.
There have been postmarketing reports of acute renal failure, hepatic failure and cytopenias. Renal failure requiring temporary or permanent dialysis, renal tubulopathy and interstitial nephritis have been reported. Upper gastrointestinal ulceration and hemorrhage, sometimes fatal, have been reported. Caution should be used in elderly patients due to a higher frequency of adverse reactions. Exjade is not recommended in patients with a short life expectancy (e.g., high-risk myelodysplastic syndromes), especially when co-morbidities could increase the risk of adverse events.
Skin rashes, serious hypersensitivity reactions, decreased hearing and lens opacities have been reported. The most common adverse reactions are nausea, vomiting, diarrhea, abdominal pain, rash, pruritus, non-progressive increases in serum creatinine, increased transaminases, abdominal distension, constipation, dyspepsia, proteinuria and headache.
Please see full Prescribing Information available at www.exjade.com .
About LDK378, LGX818, BYL719 and MEK162
Because these are investigational compounds, the safety and efficacy profile of LDK378, LGX818, BYL719 and MEK162 have not yet been established. Access to these investigational compounds is available only through carefully controlled and monitored clinical trials. These trials are designed to understand better the potential benefits and risks of the compound. Because of uncertainty of clinical trials, there is no guarantee that LDK378, LGX818, BYL719 and MEK162 will ever be commercially available anywhere in the world.
Because these are investigational compounds, the safety and efficacy profile of LDK378, LGX818, BYL719 and MEK162 have not yet been established. Access to these investigational compounds is available only through carefully controlled and monitored clinical trials. These trials are designed to understand better the potential benefits and risks of the compound. Because of uncertainty of clinical trials, there is no guarantee that LDK378, LGX818, BYL719 and MEK162 will ever be commercially available anywhere in the world.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "Breakthrough Therapy," "will," "potential," "advancing," "pipeline," "progress," "investigational," "working towards" or similar expressions, or by express or implied discussions regarding potential new indications or labeling for existing products, potential submissions for or approvals in any indication for investigational compounds, or regarding potential future revenues from such compounds and products. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that of the investigational compounds referred to in this release will be submitted or approved for sale in any market, or that the existing products referred to in this release will be submitted or approved for any additional indications or labeling in any market. Nor can there be any guarantee that any of the investigational compounds or products referred to in this release will achieve any particular levels of revenue in the future. In particular, management's expectations regarding such products could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
The foregoing release contains forward-looking statements that can be identified by terminology such as "Breakthrough Therapy," "will," "potential," "advancing," "pipeline," "progress," "investigational," "working towards" or similar expressions, or by express or implied discussions regarding potential new indications or labeling for existing products, potential submissions for or approvals in any indication for investigational compounds, or regarding potential future revenues from such compounds and products. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that of the investigational compounds referred to in this release will be submitted or approved for sale in any market, or that the existing products referred to in this release will be submitted or approved for any additional indications or labeling in any market. Nor can there be any guarantee that any of the investigational compounds or products referred to in this release will achieve any particular levels of revenue in the future. In particular, management's expectations regarding such products could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 129,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visithttp://www.novartis.com.
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 129,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visithttp://www.novartis.com.
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*Known as Gleevec® (imatinib mesylate) tablets in the US, Canada and Israel.
** MEK162 is licensed from Array BioPharma Inc.
** MEK162 is licensed from Array BioPharma Inc.
References
1 American Society of Clinical Oncology. ASCO Annual '13 Meeting Program. Available at: http://abstracts2.asco.org/. Accessed May 2013.
2 European Hematology Association. EHA Annual Meeting Program. Available at:https://b-com.mci-group.com/EventProgramme/EHA18.aspx. Accessed May 2013.
1 American Society of Clinical Oncology. ASCO Annual '13 Meeting Program. Available at: http://abstracts2.asco.org/. Accessed May 2013.
2 European Hematology Association. EHA Annual Meeting Program. Available at:https://b-com.mci-group.com/EventProgramme/EHA18.aspx. Accessed May 2013.
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