Novartis highlights extensive data on numerous compounds at ASCO in multiple cancers, including Phase III studies in GIST and myelofibrosis
- Plenary presentation of Phase III study examining benefit of extended adjuvant treatment with Gleevec® for three years vs. one year for patients with KIT+ GIST
- Two positive Phase III studies of INC424 (ruxolitinib) in myelofibrosis, a severely debilitating blood cancer with limited treatment options
- Sub-analysis from ENESTnd comparing Tasigna® to Gleevec as first-line therapy in Ph+ CML-CP showing fewer mutations emerge with Tasigna than Gleevec
- Data for novel PI3K inhibitor BEZ235, TKI258 (dovitinib), LDE225 and LBH589 (panobinostat) showing strength and depth of pipeline
EAST HANOVER, N.J., June 1, 2011 /PRNewswire/ -- Novartis Pharmaceuticals Corporation ("Novartis") will showcase data from 140 abstracts on its current oncology products and investigational agents at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO). These data underscore the company's commitment to developing treatments to improve the lives of patients with cancer.
"Through our commitment to R&D and collaborations with the scientific and patient communities, we continue to bring targeted treatments to patients living with cancer and other diseases for which there is an unmet need," said Hervé Hoppenot, President, Novartis Oncology. "Our broad and deep portfolio of development programs gives us multiple opportunities to further advance treatments for the millions of patients and their families affected by these diseases."
Highlighted at the ASCO meeting, taking place from June 3 - 7 in Chicago, will be results from key Phase III studies on Novartis products and compounds, including a trial on adjuvant treatment with Gleevec® (imatinib mesylate) tablets* in patients following resection of KIT (CD117)-positive gastrointestinal stromal tumors (GIST) featured at the plenary session on June 5, and two pivotal studies of the Janus kinase (JAK) inhibitor, INC424 (ruxolitinib), in patients with myelofibrosis on June 6(1). In addition, a study of patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), showing patients on Tasigna® (nilotinib) 150 mg capsules are less likely to develop mutations than those taking Gleevec, will be presented on June 6(1).
Also featured at the Annual Congress will be results from two sub-analyses of the landmark Medical Research Council Myeloma IX clinical trial comparing the effect of Zometa® (zoledronic acid) Injection versus clodronate, on overall survival, progression-free survival and skeletal-related events when used with first-line chemotherapy in newly diagnosed multiple myeloma patients(1). Final results of the international Phase IV study, REACT (RAD001 Expanded Access Clinical Trial in RCC), evaluating Afinitor® (everolimus) tablets for the treatment of advanced renal cell carcinoma following any available vascular endothelial growth factor targeted therapy, will also be presented(1).
Notable data about Novartis treatments at ASCO include:
- Gleevec – Two studies on Gleevec in KIT+ GIST, including a Phase III trial examining the benefit of extended adjuvant treatment for three years versus one year with Gleevec for patients following resection of their KIT+ GIST (ASCO abstract #LBA1; June 5, 1:45 - 2:00 PM CDT) and long-term follow up of the pivotal Phase II trial examining overall survival and progression-free rates in patients with metastatic and/or inoperable GIST treated for nearly 10 years with Gleevec (ASCO abstract #10016; June 4, 8:00 AM - 1:00 PM CDT).
- INC424 – Data from two pivotal Phase III studies evaluating INC424 in patients with myelofibrosis after 48 weeks of treatment compared to best available therapy in the COMFORT-II trial (ASCO abstract #LBA6501; June 6, 9:45 - 10:00 AM CDT), and after 24 weeks of treatment compared to placebo in COMFORT-I (ASCO abstract #6500; June 6, 9:30 - 9:45 AM CDT).
- Tasigna – Mutation analysis from ENESTnd comparing Tasigna to Gleevec in patients with newly diagnosed Ph+ CML in chronic phase (ASCO abstract #6502; June 6, 10:00 - 10:15 AM CDT) and ENESTnd 24-month update (ASCO abstract #6511; June 3, 2:00 - 6:00 PM CDT).
- Zometa – Two new Myeloma IX analyses evaluate the impact of treatment initiation and duration, and baseline bone disease status, on the effect of Zometa versus clodronate on progression-free survival, overall survival and skeletal-related events when used with first-line chemotherapy in patients with newly diagnosed multiple myeloma (ASCO abstract #8011; June 5, 11:00 - 11:15 AM CDT; ASCO abstract #8010; June 5, 10:45 - 11:00 AM CDT), as well as Austrian Breast & Colorectal Cancer Study Group Trial 12 (ABCSG-12) long-term follow-up data examining the impact of adjuvant Zometa therapy on disease-free survival and overall survival in premenopausal women with endocrine-responsive early breast cancer based on patient and tumor characteristics (ASCO abstract #520; June 7, 8:00 AM - 12:30 PM CDT).
- Afinitor – Two Phase IV studies evaluating Afinitor treatment for advanced renal cell carcinoma following vascular endothelial growth factor targeted therapy (ASCO abstract #4601; June 5, 8:00 AM - 12:00 PM CDT; ASCO abstract #4552; June 7, 8:00 AM - 12:30 PM CDT), as well as data from three studies examining Afinitor as a treatment for certain patients with advanced neuroendocrine tumors, including two Phase III trials and one Phase I combination study with SOM230 (pasireotide) (ASCO abstract #4009; June 6, 2:00 - 6:00 PM CDT; ASCO abstract #4011; June 6, 2:00 - 6:00 PM CDT; ASCO abstract #4120; June 4, 8:00 AM - 12:00 PM CDT).
- BEZ235 – Phase I dose escalation study of PI3K inhibitors in patients with advanced solid tumors (ASCO abstract #3066; June 6, 8:00 AM - 12:00 PM CDT).
- TKI258 (dovitinib) – Two Phase II studies examining dovitinib in FGFR1 amplified and non-amplified advanced breast cancer and in patients with advanced renal cell carcinoma (ASCO abstract #508; June 5, 10:30 - 10:45 AM CDT; ASCO abstract #4551; June 7, 8:00 AM - 12:30 PM CDT).
- LDE225 – An updated safety, preliminary efficacy and pharmacokinetic/ pharmacodynamic analysis from a Phase I study of the smoothened inhibitor in advanced solid tumors (ASCO abstract #3062; June 6, 8:00 AM - 12:00 PM CDT).
- LBH589 (panobinostat) – An update of a Phase Ib study of oral panobinostat in combination with bortezomib in patients with relapsed or relapsed and refractory multiple myeloma (ASCO abstract #8075; June 6, 1:00 - 5:00 PM CDT) and a Phase III trial in progress of panobinostat plus bortezomib in relapsed/refractory multiple myeloma: PANORAMA-1, which is currently enrolling (ASCO abstract #TPS227; June 6, 8:00 AM - 12:00 PM CDT).
Gleevec® (imatinib mesylate) tablets are indicated for newly diagnosed adult and pediatric patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in the chronic phase and for patients with Ph+ CML in blast crisis (BC), accelerated phase (AP) or in the chronic phase (CP) after failure of interferon-alpha therapy. Gleevec is also indicated for the treatment of patients with KIT (CD117)–positive gastrointestinal stromal tumors (GIST) that are cancerous, cannot be surgically removed, and/or have spread to other parts of the body and use after surgery in patients that have had their KIT (CD117)–positive GISTs completely removed. Approval is based on survival without a return of cancer (recurrence-free survival) with a median follow-up of 14 months. Clinical benefit has not been demonstrated by a long term effect on recurrence-free survival or survival.
Gleevec Important Safety Information
Gleevec can cause fetal harm when administered to a pregnant woman. Women should not become pregnant, and should be advised of the potential risk to the unborn child.
Gleevec is often associated with edema (swelling) and serious fluid retention. Studies have shown that edema (swelling) tended to occur more often among patients who are 65 and older or those taking higher doses of Gleevec.
Cytopenias (reduction or lack of certain cell elements in blood circulation), such as anemia, have occurred. If the cytopenia is severe, your doctor may reduce your dose or temporarily stop your treatment with Gleevec.
Severe congestive heart failure and left ventricle dysfunction have been reported, particularly in patients with other health issues and risk factors. Patients with heart disease or risk factors will be monitored and treated for the condition.
Severe liver problems (hepatotoxicity) may occur. Cases of fatal liver failure and severe liver injury requiring liver transplants have been reported with both short-term and long-term use of Gleevec.
Bleeding may occur. Severe gastrointestinal (GI) bleeding has been reported in patients with Ph+ CML and KIT+ GIST. GI tumor sites may be the cause of this bleeding.
In patients with hypereosinophilic syndrome (a condition with increased eosinophils, which are a type of white blood cell), e.g., HES, MDS/MPD, or ASM and heart involvement, cases of heart disease (cardiogenic shock/left ventricular dysfunction) have been associated with the initiation of Gleevec therapy. Skin reactions, such as fluid-filled blisters, have been reported with the use of Gleevec.
Clinical cases of hypothyroidism (reduction in thyroid hormones) have been reported in patients taking levothyroxine replacement with Gleevec.
Long-term use may result in potential liver, kidney, and/or heart toxicities; immune system suppression may also result from long-term use.
GI perforation (small holes or tears in the walls of the stomach or intestine), in some cases fatal, has been reported.
Growth retardation has been reported in children taking Gleevec. The long-term effects of extended treatment with Gleevec on growth in children are unknown.
Cases of tumor lysis syndrome (TLS), which refers to a metabolic and electrolyte disturbance caused by the breakdown of tumor cells, have been reported and can be life-threatening in some cases.
Almost all patients treated with Gleevec experience side effects at some time. Some common side effects you may experience are fluid retention, muscle cramps or pain and bone pain, abdominal pain, loss of appetite, vomiting, diarrhea, decreased hemoglobin, abnormal bleeding, nausea, fatigue and rash.
Gleevec is sometimes associated with stomach or intestinal irritation. Gleevec should be taken with food and a large glass of water to minimize this problem. There have been rare reports, including deaths, of stomach or intestinal perforation (a small hole or tear).
If you are experiencing any of the mentioned side effects, please be sure to speak with your doctor immediately.
Do not take any other medications without talking to your doctor or pharmacist first, including Tylenol® (acetaminophen); herbal products (St. John's wort, Hypericum perforatum); Coumadin® (warfarin sodium); rifampin; erythromycin; metoprolol; ketoconazole; and Dilantin® (phenytoin). Taking these with Gleevec may affect how they work, or affect how Gleevec works.
You should also tell your doctor if you are taking or plan to take iron supplements. Patients should also avoid grapefruit juice and other foods that may affect how Gleevec works.
INC424 is an oral inhibitor, of the JAK1 and JAK2 tyrosine kinases. INC424 is being investigated in primary myelofibrosis as well as post-polycythemia vera myelofibrosis (PPV-MF) and post-essential thrombocythemia myelofibrosis (PET-MF). INC424 is also being investigated in clinical trials for the treatment of polycythemia vera (PV).
Novartis licensed INC424 from Incyte for development and potential commercialization outside the US. Incyte has retained rights for the development and potential commercialization of INC424 in the US. Both the European Commission (EC) and the US Food and Drug Administration (FDA) have granted INC424 orphan drug status for myelofibrosis.
Tasigna® (nilotinib) 150 mg capsules is approved for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The effectiveness of Tasigna for this indication is based on major molecular response and cytogenetic response rates at 12 months. The study is ongoing and further data will be required to determine long-term outcome.
Tasigna® (nilotinib) 200 mg capsules is also approved in more than 90 countries for the treatment of chronic phase and accelerated phase Ph+ CML in adult patients resistant or intolerant to at least one prior therapy, including Gleevec. The effectiveness of Tasigna for this indication is based on hematologic and cytogenetic response rates.
TASIGNA BOXED WARNING and Additional Important Safety Information
TASIGNA (nilotinib) prolongs the QT interval. Sudden deaths have been reported in patients receiving TASIGNA. TASIGNA should not be used in patients with hypokalemia, hypomagnesemia, or long QT syndrome. Hypokalemia or hypomagnesemia must be corrected prior to TASIGNA administration and should be periodically monitored. Drugs known to prolong QT interval and strong CYP3A4 inhibitors should be avoided. Patients should avoid food 2 hours before and 1 hour after taking dose. A dose reduction is recommended in patients with hepatic impairment.
ECGs should be obtained to monitor the QTc at baseline, 7 days after initiation and periodically thereafter, as well as following any dose adjustments.
- Treatment with TASIGNA can cause Grade 3/4 thrombocytopenia, neutropenia and anemia. Complete blood counts should be performed every 2 weeks for the first 2 months and then monthly thereafter.
- Caution is recommended in patients with a history of pancreatitis.
- The use of TASIGNA may result in elevations in bilirubin, AST/ALT and alkaline phosphatase.
- TASIGNA can cause hypophosphatemia, hypokalemia, hyperkalemia, hypocalcemia and hyponatremia (see Boxed WARNING).
- The concomitant use of strong CYP3A4 inhibitors or anti-arrhythmic drugs (including, but not limited to, amiodarone, disopyramide, procainamide, quinidine and sotalol) and other drugs that may prolong the QT interval (including, but not limited to, chloroquine, clarithromycin, haloperidol, methadone, moxifloxacin and pimozide) should be avoided. Grapefruit products should also be avoided.
- The concomitant use of strong CYP3A4 inducers should be avoided (including, but not limited to, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital and St. John's wort).
- TASIGNA must not be taken with food.
- TASIGNA exposure is increased in patients with impaired hepatic function.
- The exposure of TASIGNA is reduced in patients with total gastrectomy.
- Since the capsules contain lactose, TASIGNA is not recommended for patients with rare hereditary problems of galactose intolerance, severe lactase deficiency with a severe degree of intolerance to lactose-containing products or of glucose-galactose malabsorption.
- Women of childbearing potential should avoid becoming pregnant while taking TASIGNA and should be advised of the potential hazard to the fetus if they do. The safety and effectiveness of TASIGNA in pediatric patients have not been established.
- In newly diagnosed Ph+ CML-chronic phase, the most commonly reported nonhematologic adverse drug reactions (>10%) were rash, pruritus, headache, nausea, fatigue and myalgia.
- In resistant or intolerant Ph+ CML-chronic phase, the most commonly reported nonhematologic adverse drug reactions (>10%) were rash, pruritus, nausea, fatigue, headache, constipation, diarrhea, vomiting and myalgia.
- In resistant or intolerant Ph+ CML-accelerated phase, the most commonly reported nonhematologic adverse drug reactions (>10%) were rash, pruritus and fatigue.
- TASIGNA may need to be temporarily withheld and/or dose reduced for QT prolongation, hematologic toxicities that are not related to underlying leukemia, clinically significant moderate or severe nonhematologic toxicities, laboratory abnormalities or concomitant use of strong CYP3A4 inhibitors.
Please see full Prescribing Information.
About the compounds BEZ235, TKI258 (dovitinib), LDE225 and LBH589 (panobinostat)
Because these are investigational compounds, the safety and efficacy profile of BEZ235, TKI258 (dovitinib), LDE225 and LBH589 (panobinostat) have not yet been fully established. Access to these investigational compounds is available only through carefully controlled and monitored clinical trials. These trials are designed to better understand the potential benefits and risks of the compound. Because of uncertainty of clinical trials, there is no guarantee that BEZ235, TKI258 (dovitinib), LDE225 and LBH589 (panobinostat) will ever be commercially available anywhere in the world.
ZOMETA (zoledronic acid) 4 mg/5 mL Injection is a treatment for hypercalcemia of malignancy (HCM; a condition resulting in high calcium blood levels due to cancer). ZOMETA is also used to reduce and delay bone complications due to multiple myeloma and bone metastases from solid tumors; used with anti-cancer medicines. ZOMETA is not an anti-cancer therapy. If you have prostate cancer, you should have failed treatment with at least one hormonal therapy prior to taking ZOMETA.
ZOMETA Important Safety Information
Do not use ZOMETA if you have had a severe allergic reaction to zoledronic acid or any components of ZOMETA. These reactions, including rare cases of hives and angioedema (swelling often near your eyes and lips), and very rare cases of life-threatening allergic reactions, have been reported. ZOMETA is in a class of drugs called bisphosphonates, and contains the same active ingredient as that found in Reclast® (zoledronic acid). If you are treated with ZOMETA, you should not be treated with Reclast.
If you have HCM, you should drink plenty of clear fluids before using ZOMETA. If you have kidney problems, tell your doctor. The risk of adverse reactions (especially related to the kidney) may be greater for you. ZOMETA treatment is not for patients with severe kidney problems. Patients with kidney problems on multiple cycles of ZOMETA or other bisphosphonates are at greater risk for further kidney problems. It is important to get your blood tests while you are receiving ZOMETA. Your doctor will monitor your kidney function before each dose. Tell your doctor if you are on other drugs, including aminoglycosides, loop diuretics, and drugs which may be harmful to the kidney.
Osteonecrosis of the jaw (ONJ) has been reported mainly in cancer patients treated with intravenous bisphosphonates, including ZOMETA. Many of these patients were also receiving anti-cancer drugs and corticosteroids, which may make it more likely to get ONJ. If you have advanced breast cancer or a type of cancer called multiple myeloma, or if you have had dental extraction, periodontal disease, local trauma, including poorly fitting dentures, you may be at greater risk of getting ONJ. Many reports of ONJ involved patients with signs of local infection, including bone/bone marrow inflammation. You should maintain good oral hygiene and have a dental examination with preventive dentistry prior to beginning ZOMETA. While on treatment, avoid invasive dental procedures, if possible, as recovery may take longer. If you develop ONJ while on bisphosphonate therapy, dental surgery may worsen the condition. If you require dental procedures, there are no data available to suggest whether stopping ZOMETA treatment reduces the risk of ONJ. A causal relationship between bisphosphonate use and ONJ has not been established. Based on your condition, your doctor will determine the treatment plan you will receive.
Do not use ZOMETA if you are pregnant or plan to become pregnant, or if you are breast-feeding.
Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates, including ZOMETA. Do not continue using ZOMETA if severe symptoms develop, as some patients had the symptoms reappear after taking ZOMETA or another bisphosphonate again. In aspirin sensitive patients, bronchoconstriction (tightening of the airways in the lungs) has been observed while taking bisphosphonates.
If you are an HCM patient with liver problems, talk to your doctor about whether ZOMETA is appropriate for you.
HCM patients may experience flu-like symptoms (fever, chills, flushing, bone pain and/or joint or muscle pain). Common side effects in HCM patients include fever, nausea, constipation, anemia, shortness of breath, diarrhea, abdominal pain, worsening of cancer, insomnia, vomiting, anxiety, urinary tract infection, low phosphate levels, confusion, agitation, a fungal infection called moniliasis, low potassium levels, coughing, skeletal pain, low blood pressure, and low magnesium levels. Redness and swelling may occur at the site that you are injected.
Common side effects for patients with multiple myeloma and bone metastases due to solid tumors include bone pain, nausea, fatigue, anemia, fever, vomiting, constipation, shortness of breath, diarrhea, weakness, muscle pain, anorexia, cough, joint pain, lower-limb swelling, worsening of your cancer, headache, dizziness (excluding vertigo), insomnia, decreased weight, back pain, numbness/tingling, and abdominal pain. These side effects are listed regardless of any potential association with the medications used in registration studies of ZOMETA in bone metastases patients.
Eye-related side effects may occur with bisphosphonates, including ZOMETA. Cases of swelling related to fluid build-up in the eye, as well as inflammation of the uvea, sclera, episclera, conjunctiva, and iris of the eye have been reported.
Patients with multiple myeloma and bone metastases from solid tumors should be taking an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of vitamin D daily.
Please see full Prescribing Information and talk to your doctor for more information.
About AFINITOR (everolimus)
AFINITOR® (everolimus) tablets is approved in the US for the treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease. The safety and effectiveness of AFINITOR in the treatment of patients with carcinoid tumors have not been established.
AFINITOR is approved in the US for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib and in the European Union (EU) for the treatment of patients with advanced RCC whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy.
AFINITOR is also approved in the US to treat patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis who require therapeutic intervention but are not candidates for curative surgical resection. The effectiveness of AFINITOR is based on an analysis of change in SEGA volume. Clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been shown. In Switzerland, everolimus is approved with the trade name Votubia® (everolimus) tablets for the treatment of patients 3 years of age and older with SEGA associated with tuberous sclerosis for whom surgery is not a suitable option. Novartis has submitted marketing applications for everolimus for this use to the European Medicines Agency (EMA) and additional regulatory submissions are under way worldwide.
AFINITOR is available in the US in 2.5 mg, 5 mg and 10 mg tablet strengths.
In the US, everolimus is available in different dosage strengths for the non-oncology patient population under the trade name Zortress® for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant. In the EU, everolimus is available in different dosage strengths under the trade name Certican® for the prevention of organ rejection in heart and kidney transplant recipients.
Everolimus is exclusively licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents.
Not all indications are available in every country. As an investigational compound the safety and efficacy profile of everolimus has not yet been established in all countries in pancreatic or any other type of NET, or in locally-advanced or metastatic breast cancer. Access to everolimus outside of the approved indications has been carefully controlled and monitored in clinical trials designed to better understand the potential benefits and risks of the compound. Because of the uncertainty of clinical trials, there is no guarantee that everolimus will become commercially available for pancreatic or any other type of NET, locally-advanced or metastatic breast cancer or additional indications anywhere else in the world.
Important Safety Information about AFINITOR (everolimus) tablets
Patients should not take AFINITOR if they are allergic to AFINITOR or to any of its ingredients. Patients should tell their healthcare provider before taking AFINITOR if they are allergic to sirolimus (Rapamune®#) or temsirolimus (Torisel®#).
AFINITOR can cause serious side effects including lung or breathing problems, infections and kidney failure, which can lead to death. If patients experience these serious side effects, they may need to stop taking AFINITOR for a while or use a lower dose. Patients should tell their healthcare provider right away if they have any of these symptoms: new or worsening cough, shortness of breath, chest pain, difficulty breathing or wheezing.
AFINITOR may make patients more likely to develop an infection, such as pneumonia, or a bacterial, fungal or viral infection. Viral infections may include reactivation of hepatitis B in people who have had hepatitis B in the past. In some people these infections may be severe, and can even lead to death. Patients may need to be treated as soon as possible. Patients should tell their healthcare provider right away if they have a temperature of 100.5˚F or above, chills or do not feel well. Symptoms of hepatitis B or infection may include the following: fever, skin rash, joint pain and inflammation, tiredness, loss of appetite, nausea, pale stool or dark urine, yellowing of the skin or pain in the upper right side.
AFINITOR can cause mouth ulcers and sores, which are the most frequently occurring side effects occurring in approximately 44%-64% advanced kidney cancer and advanced pancreatic NET patients taking AFINITOR. Eighty-six percent of patients taking AFINITOR for SEGA developed mouth ulcers/sores. Patients should tell their healthcare provider if they have pain, discomfort or open sores in their mouth. Their healthcare provider may tell them to use a special mouthwash or mouth gel that does not contain alcohol or peroxide.
AFINITOR may cause kidney failure. In some people this may be severe and can even lead to death. Patients should have tests to check their kidney function before and during their treatment with AFINITOR.
Patients will have regular blood tests before they start and as needed during their treatment with AFINITOR. These tests will include tests to check the patient's blood cell count, kidney and liver function and blood sugar levels. Patients who receive AFINITOR for the treatment of SEGA will need regular blood tests to measure how much AFINITOR is in their blood since this will help their doctor decide how much AFINITOR they need to take.
AFINITOR may affect the way other medicines work, and other medicines can affect how AFINITOR works. Using AFINITOR with other medicines can cause serious side effects. Patients should tell their healthcare provider about all of the medicines they take, including prescription and non-prescription medicines, vitamins and herbal supplements such as: St. John's Wort, and medicine for fungal infections, bacterial infections, tuberculosis, seizures, HIV-AIDS, heart conditions or high blood pressure and medicines that suppress their immune system. Patients should not drink grapefruit juice or eat grapefruit during their treatment with AFINITOR as it may make the amount of AFINITOR in their blood increase to a harmful level.
Patients should not take AFINITOR tablets which are broken or crushed. Patients should not chew or crush the tablets.
The amount of AFINITOR in the blood was increased in patients who had liver problems. Patients should tell their healthcare provider about all their medical conditions, including if they have or have had liver problems, diabetes or high blood sugar, high cholesterol levels, infections, hepatitis B or other medical conditions.
Patients should tell their healthcare provider if they are scheduled to receive any vaccinations. Patients should not receive a live vaccine or be around people who have recently received a live vaccine during treatment with AFINITOR.
It is not known if AFINITOR will harm an unborn baby. Women should use effective birth control while using AFINITOR and for eight weeks after stopping treatment.
Common side effects of AFINITOR in patients with advanced pancreatic neuroendocrine tumors include mouth ulcers, rash, diarrhea, swelling of arms, hands, feet, ankles, face or other parts of the body, abdominal pain, nausea, fever and headache. Common side effects of AFINITOR in patients with advanced kidney cancer include mouth ulcers, infections, feeling weak or tired, cough and diarrhea. Common side effects of AFINITOR in patients with SEGA include mouth ulcers, infections of the respiratory tract, sinuses and ears and fever.
Please see full Prescribing Information for AFINITOR.
# Rapamune® (sirolimus) and Torisel® (temsirolimus) are registered trademarks of Wyeth Pharmaceuticals Inc.
About SOM230 (pasireotide)
SOM230 is an investigational multireceptor targeting somatostatin analog (SSA) that binds to four of the five somatostatin receptor subtypes (sst 1, 2, 3 and 5).
Because it is an investigational compound, the tolerability and efficacy profile of SOM230 has not yet been fully established. Access to this investigational compound is available only through carefully controlled and monitored clinical trials. These trials are designed to better understand the potential benefits and risks of the compound. There is no guarantee that SOM230 will become commercially available.
Information about Novartis clinical trials for SOM230 can be obtained by healthcare professionals at www.pasporttrials.com.
The foregoing release contains forward-looking statements that can be identified by terminology such as "pipeline," "will," "commitment," "potential," or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, or regarding potential future revenues from any such 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 any new products will be submitted or approved for sale in any market, or that any new indications will be submitted or approved for existing products in any market, or at any particular time, or that such products will achieve any particular revenue levels. In particular, management's expectations 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; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; 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.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, which provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, consumer health products, preventive vaccines and diagnostic tools. Novartis is the only company with leading positions in these areas. In 2010, the Group's continuing operations achieved net sales of USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 119,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.us.novartis.com.
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* Known as Glivec® (imatinib) outside the US, Canada and Israel.
(1) American Society of Clinical Oncology. ASCO Annual '11 Meeting Program. Available at: http://chicago2011.asco.org/MeetingProgram.aspx. Accessed May 2011.
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