|By PR Newswire||
|December 4, 2013 01:21 AM EST||
EAST HANOVER, N.J., Dec. 4, 2013 /PRNewswire/ -- Novartis will present updates on its broad cancer portfolio with more than 240 abstracts at the upcoming American Society of Hematology (ASH) annual meeting and CTRC-AACR San Antonio Breast Cancer Symposium (SABCS). Presentations will provide key scientific evidence for targeted treatments in chronic myeloid leukemia (CML), myelofibrosis (MF) and advanced breast cancer, as well as emerging information on pipeline compounds1,2. "Cancer treatment has been revolutionized by targeted therapies, which have established a highly successful approach to the management of many cancers," said Herve Hoppenot, President, Novartis Oncology. "At this exciting time in cancer research, we are presenting new long-term findings on well-established, targeted therapies while also reporting early data on innovative treatment approaches and compounds in areas of high unmet patient need, including acute lymphoblastic leukemia, chronic lymphocytic leukemia and advanced breast cancer." Novartis Oncology has 24 pivotal trials underway and more than 25 new molecular entities in development targeting key oncogenic pathways and covering a wide range of mutations. The ASH annual meeting in New Orleans, held December 7-10, will feature data assessing the overall survival rates for Jakavi® (ruxolitinib) in MF, and multiple studies evaluating deep molecular responses with Tasigna® (nilotinib) compared with Gleevec® (imatinib)* therapy in a variety of appropriate Philadelphia chromosome-positive CML (Ph+ CML) patient populations1. Novartis Oncology will also share updated efficacy data on Exjade® (deferasirox) in transfusion-dependent thalassemia major patients with severe cardiac iron overload1. Pipeline advances will also be presented, including additional outcomes data in patients with relapsed, refractory acute lymphoblastic leukemia (ALL) and relapsed, refractory chronic lymphocytic leukemia (CLL) treated with chimeric antigen receptor (CAR) modified T cells directed against CD19 (CTL019)1. At CTRC-AACR SABCS, held December 10-14, Novartis Oncology will present data for its mTOR inhibitor Afinitor® (everolimus) and provide updates on the clinical development of investigational PI3K inhibitors BKM120 (buparlisib) and BYL719 in breast cancer2.
EAST HANOVER, N.J., Dec. 4, 2013 /PRNewswire/ -- Novartis will present updates on its broad cancer portfolio with more than 240 abstracts at the upcoming American Society of Hematology (ASH) annual meeting and CTRC-AACR San Antonio Breast Cancer Symposium (SABCS). Presentations will provide key scientific evidence for targeted treatments in chronic myeloid leukemia (CML), myelofibrosis (MF) and advanced breast cancer, as well as emerging information on pipeline compounds1,2.
"Cancer treatment has been revolutionized by targeted therapies, which have established a highly successful approach to the management of many cancers," said Herve Hoppenot, President, Novartis Oncology. "At this exciting time in cancer research, we are presenting new long-term findings on well-established, targeted therapies while also reporting early data on innovative treatment approaches and compounds in areas of high unmet patient need, including acute lymphoblastic leukemia, chronic lymphocytic leukemia and advanced breast cancer."
Novartis Oncology has 24 pivotal trials underway and more than 25 new molecular entities in development targeting key oncogenic pathways and covering a wide range of mutations.
The ASH annual meeting in New Orleans, held December 7-10, will feature data assessing the overall survival rates for Jakavi® (ruxolitinib) in MF, and multiple studies evaluating deep molecular responses with Tasigna® (nilotinib) compared with Gleevec® (imatinib)* therapy in a variety of appropriate Philadelphia chromosome-positive CML (Ph+ CML) patient populations1. Novartis Oncology will also share updated efficacy data on Exjade® (deferasirox) in transfusion-dependent thalassemia major patients with severe cardiac iron overload1. Pipeline advances will also be presented, including additional outcomes data in patients with relapsed, refractory acute lymphoblastic leukemia (ALL) and relapsed, refractory chronic lymphocytic leukemia (CLL) treated with chimeric antigen receptor (CAR) modified T cells directed against CD19 (CTL019)1.
At CTRC-AACR SABCS, held December 10-14, Novartis Oncology will present data for its mTOR inhibitor Afinitor® (everolimus) and provide updates on the clinical development of investigational PI3K inhibitors BKM120 (buparlisib) and BYL719 in breast cancer2.
Highlights at ASH include:
- Long-term, five-year update from the ENESTnd study evaluating superiority of Tasigna versus Gleevec in patients with newly diagnosed Ph+ CML in chronic phase (Abstract #92; December 8, 5:15 PM)
- Three-year data from the ENESTcmr study evaluating sustained deep molecular response following a switch to Tasigna in patients with Ph+ CML in chronic phase who still had evidence of residual disease after two or more years of Gleevec therapy (Abstract #94; December 8, 5:45 PM)
- LASOR, a Phase III study comparing the efficacy of Tasigna to Gleevec in patients with Ph+ CML in chronic phase who have a suboptimal cytogenetic response to Gleevec (Abstract #95; December 8, 6:00 PM)
- Long-term pooled overall survival results from the COMFORT-I and COMFORT-II Phase III trials studying the safety and efficacy of Jakavi in patients with MF (Abstract #2820; December 8, 6:30 PM)
- Long-term overall survival results from COMFORT-I with responses reported through 132 weeks (Abstract #396; December 9, 11:45 AM)
- New analyses of COMFORT-II survival data examining the impact of Jakavi on patients with low- and high-risk molecular mutations (Abstract #107; December 8, 6:00 PM)
- An evaluation of overall survival among COMFORT-II patients compared to a historical control group of MF patients (Abstract #4066; December 9, 6:00 PM)
- Baseline characteristics and symptom burden in the RESPONSE trial, a Phase III study comparing safety and efficacy of Jakavi with best available treatment in polycythemia vera patients (Abstract #4071; December 9, 6:00 PM)
- Two-year results from CORDELIA, the first head-to-head multicenter, randomized, open-label trial evaluating Exjade compared with deferoxamine for the removal of cardiac iron in patients with beta-thalassemia major (Abstract #1018; December 7, 5:30 PM)
- Twelve-month data from the HYPERION study investigating the combination therapy of deferasirox–deferoxamine in treating transfusion-dependent thalassemia patients with severe cardiac siderosis (Abstract #2257; December 8, 6:30 PM)
- Forty-eight-month results from five-year non-interventional registry of lower-risk MDS patients with transfusional iron overload comparing survival and acute myeloid leukemic transformation status in chelated and non-chelated patients (Abstract #2775; December 8, 6:30 PM)
- Quality of life results and updated duration of response and overall survival data of PKC412 in patients with advanced systemic mastocytosis (Abstract #106; December 8, 5:45 PM)
- Additional outcomes from long-term follow-up in children and adults with relapsed, refractory ALL treated with CTL019 (Abstract #67; December 8, 5:00 PM)
- Outcomes from Phase I/II long-term follow-up and dose optimization studies in patients with relapsed, refractory CLL treated with CAR modified T cells directed against CD19 (CTL019) (Abstract #4162; December 9, 6:00 PM; Abstract #873; December 10, 8:00 AM)
- Preclinical study of disease modifying effects of the combination of JAK2 and Hedgehog inhibitors in the treatment of myelofibrosis (Abstract #666; December 9, 5:45 PM)
- Progression-free survival and overall survival data from PANORAMA-II, a Phase II study of panobinostat, bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma (Abstract #1970; December 7, 5:30 PM)
- Identification of the recommended Phase II dose of ruxolitinib plus panobinostat in patients with primary myelofibrosis, post-polycythemia vera or post-essential thrombocythemia MF (Abstract #4045; December 9, 6:00 PM)
Highlights at SABCS include:
- Updates on Afinitor in advanced HR+/HER2 negative breast cancer include a BOLERO-2 study analysis characterizing patient responses to everolimus plus exemestane (Abstract #P2-16-17; December 12, 7:30 AM)
- New BOLERO-3 study analyses looking at the impact of a combination therapy including everolimus, trastuzumab and vinorelbine on safety and quality of life in HER2 positive advanced breast cancer patients who are resistant to trastuzumab and have been pre-treated with a taxane (Abstract #P3-15-03; December 12, 5:00 PM; Abstract #P4-12-18; December 13, 7:30 AM)
- Additional analysis of BOLERO-3 evaluating efficacy of the everolimus combination therapy in a subset of Asian patients will be presented (Abstract #P4-12-19; December 13, 7:30 AM)
- A Trials in Progress poster presentation of the Phase II BELLE-4 study of BKM120 in combination with paclitaxel in patients with HER2 negative locally advanced or metastatic breast cancer, with or without PI3K activation (Abstract #OT2-6-07; December 12, 5:00 PM)
- A Trials in Progress poster presentation of the Phase II NeoPHOEBE study of BKM120 in combination with trastuzumab and paclitaxel in patients with HER2 positive, PIK3CA mutated and PIK3CA wild-type primary breast cancer (Abstract #OT2-6-08; December 12, 5:00 PM)
- Phase I data of BYL719 in combination with fulvestrant in patients with PIK3CA mutated estrogen-receptor positive (ER+) breast cancer (Abstract #P2-16-14; December 12, 7:30 AM)
TASIGNA® (nilotinib) 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 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.
BOXED WARNING and Important Safety Information for TASIGNA (nilotinib):
WARNING: QT PROLONGATION AND SUDDEN DEATHS TASIGNA prolongs the QT interval. Prior to TASIGNA administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies. Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and follow any dose adjustments. Sudden deaths have been reported in patients receiving nilotinib. Do not administer TASIGNA to patients with hypokalemia, hypomagnesemia, or long QT syndrome. Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors.
WARNING: QT PROLONGATION AND SUDDEN DEATHS
TASIGNA prolongs the QT interval. Prior to TASIGNA administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies. Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and follow any dose adjustments.
Sudden deaths have been reported in patients receiving nilotinib. Do not administer TASIGNA to patients with hypokalemia, hypomagnesemia, or long QT syndrome.
Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors.
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.
Cases of tumor lysis syndrome have been reported in TASIGNA treated patients with resistant or intolerant CML. Due to potential for tumor lysis syndrome, maintain adequate hydration and correct uric acid levels prior to initiating therapy with TASIGNA.
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 (greater than or equal to 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 (greater than or equal to 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 including Boxed Warning.
Gleevec® (imatinib mesylate) tablets are indicated for newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase (CP). Gleevec is also indicated for the treatment of patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in CP after failure of interferon-alpha therapy.
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 or history of renal failure 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 KIT+ GIST. GI tumor sites may be the cause of this bleeding; therefore, GI symptoms should be monitored at the start of treatment.
In patients with hypereosinophilic syndrome (a condition with increased eosinophils, which are a type of white blood cell) 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. Correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of GLEEVEC.
Reports of motor vehicle accidents have been received in patients receiving GLEEVEC. Caution patients about driving a car or operating machinery.
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.
Please see full Prescribing Information.
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 50 countries, including 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 100,000 cubic 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 cautiously14.
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.
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 PML14.
Please see full Prescribing Information available at www.jakavi.com.
About Afinitor® (everolimus)
Afinitor® (everolimus) is approved in the United States for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2 negative breast cancer (advanced HR+/HER2 negative breast cancer) in combination with exemestane after failure of treatment with letrozole or anastrozole.
For more information visit www.AFINITOR.com or call 1-888-4-AFINITOR. US patients who may be eligible for financial assistance can learn about the Novartis Patient Assistance Now Oncology (PANO) reimbursement support program by contacting 1-800-282-7630 or visiting the Afinitor website.
In the United States, Afinitor tablets is approved for the treatment of adult patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib and for the treatment of progressive neuroendocrine tumors of pancreatic origin in adult patients with unresectable, locally advanced or metastatic disease. The US Food and Drug Administration (FDA) determined that the safety and effectiveness of Afinitor in the treatment of patients with carcinoid tumors have not been established.
Afinitor is approved in the United States to treat adult patients with renal angiomyolipomas and tuberous sclerosis complex (TSC), who do not require immediate surgery. The effectiveness of Afinitor in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. Further follow-up of patients is required to determine long-term outcomes. Afinitor is also approved in the United States to treat adult and pediatric patients, three years of age or older, with SEGA associated with TSC, who require therapeutic intervention but are not candidates for 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 the United States, Afinitor is available from Novartis in different dosage strengths and for different uses in non-oncology patient populations under the trade name Zortress®. 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. Access to Afinitor 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. As an investigational compound, the safety and efficacy profile of Afinitor has not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that Afinitor will become commercially available for additional indications anywhere else in the world.
Important Safety Information about Afinitor (everolimus) tablets
Patients should not take Afinitor or Afinitor Disperz if they are allergic to Afinitor or Afinitor Disperz or to any of its ingredients. Patients should tell their healthcare provider before taking Afinitor or Afinitor Disperz if they are allergic to sirolimus (Rapamune®) or temsirolimus (Torisel®).
Afinitor or Afinitor Disperz can cause serious side effects, including lung or breathing problems, infections, and kidney failure, which can even lead to death. If patients experience these side effects, they may need to stop taking Afinitor or Afinitor Disperz for a while or use a lower dose. Patients should follow their healthcare provider's instructions.
In some patients, lung or breathing problems may be severe and can even lead to death. 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 or Afinitor Disperz 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, chills, skin rash, joint pain and inflammation, tiredness, loss of appetite, nausea, pale stools or dark urine, yellowing of the skin, or pain in the upper right side of the stomach.
Afinitor or Afinitor Disperz 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 or Afinitor Disperz.
Common side effects include mouth ulcers. Afinitor or Afinitor Disperz can cause mouth ulcers and sores. Other common side effects include infections, feeling weak or tired, nausea and vomiting, skin problems, headache, weight loss, loss of appetite, cough, diarrhea, fever, swelling of the hands, arms, legs, feet, face, or other parts of the body, joint pain, abnormal taste, stomach-area (abdomen) pain, nose bleeds, seizure, increased blood cholesterol and sugar levels, decreased blood phosphate levels, low red and white blood cells, and the absence of menstrual periods (menstruation).
Please see full Prescribing Information for Afinitor and Afinitor Disperz available at AFINITOR.com.
Rapamune® (sirolimus) and Torisel® (temsirolimus) are registered trademarks of Wyeth Pharmaceuticals Inc.
About Exjade® (deferasirox) Tablets
Exjade is an iron chelator indicated for the treatment of chronically elevated levels of iron in the blood caused by repeated blood transfusions (transfusional hemosiderosis) in patients ages 2 years and older. Exjade is also indicated to treat patients ages 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT). In patients Exjade lowered the levels of iron in the blood (measured by serum ferritin levels) and liver (measured by liver iron concentration). An improvement in survival or disease symptoms resulting from reduction in elevated iron levels, however, has not been proven.
It is not known if Exjade is safe or effective when taken with other iron chelation therapy. Controlled clinical trials of Exjade in patients with myelodysplastic syndromes (a serious blood disorder) and chronic iron overload due to blood transfusions have not been performed.
Exjade 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.
Important safety information about Exjade
Exjade may cause serious kidney problems, liver problems, and bleeding in the stomach or intestines. In some cases, these problems were fatal. Kidney problems occurred particularly in patients with multiple medical conditions and those who were very ill because of their disease. Bleeding in the stomach or intestines occurred more often in elderly patients. Liver problems were more likely to happen in patients older than 55 years.
Exjade should not be taken by patients with pre-existing severe kidney and liver problems; high-risk myelodysplastic syndromes; advanced cancer; low platelet counts; or an allergy to Exjade.
Since Exjade has been on the market, there have been reports of serious reactions, sometimes leading to death. Severe blood disorders (including neutropenia, agranulocytosis, worsening anemia and thrombocytopenia), serious allergic reactions (including swelling of the throat), severe skin reactions (including Stevens Johnson syndrome and erythema multiforme), decreased hearing and vision changes have been reported. These serious reactions and deaths have happened most often when Exjade was taken by elderly patients. The most commonly reported side effects related to Exjade in clinical trials were nausea, vomiting, diarrhea, stomach pain, increases in kidney laboratory values, and skin rash.
Please see full Prescribing Information including Boxed WARNING available at www.exjade.com.
About PKC412, CTL019, LDE225, LBH589, BKM120 and BYL719
Because these are investigational compounds, the safety and efficacy profile of PKC412, CTL019, LDE225, LBH589, BKM120 and BYL719 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 better understand the potential benefits and risks of the compound. Because of uncertainty of clinical trials, there is no guarantee that PKC412, CTL019, LDE225, LBH589, BKM120 and BYL719 will ever be commercially available anywhere in the world.
The foregoing release contains forward-looking statements that can be identified by words such as "to highlight," "investigational," "will," "emerging," "underway," or similar terms, or by express or implied discussions regarding potential marketing approvals for PKC412, CTL019, LDE225, LBH589, BKM120 and BYL719, potential new indications or labeling for Tasigna, Gleevec, Jakavi, Afinitor, and Exjade, or regarding potential future revenues from any of the foregoing investigational compounds and products. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of PKC412, CTL019, LDE225, LBH589, BKM120 or BYL719 will be submitted or approved for sale in any market, or at any particular time, or that any of Tasigna, Gleevec, Jakavi, Afinitor, or Exjade will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that any of the foregoing investigational compounds or products will receive regulatory approval or be commercially successful in the future. In particular, management's expectations regarding such investigational compounds and products could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. 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.
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets innovative prescription drugs used to treat a number of diseases and conditions, including cardiovascular, dermatological, central nervous system, bone disease, cancer, organ transplantation, psychiatry, infectious disease and respiratory. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, which 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 133,000 full-time equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.
1. American Society of Hematology. ASH Annual 2013 Meeting Program. Available at: https://ash.confex.com/ash/2013/webprogram/start.html
2. San Antonio Breast Cancer Symposium. SABCS Annual 2013 Meeting Program. Available at: http://www.sabcs.org/ProgramSchedule/index.asp
* Known as Glivec® (imatinib) outside the US, Canada and Israel
Novartis Media Relations
Novartis Media Relations
+1 212 830 2465 (direct)
+1 862 579 8456 (mobile)
+1 862 778 1518 (direct)
+1 973 714 0063 (mobile)