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More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies

- Tasigna front-line data demonstrating potential in newly diagnosed patients with a life-threatening type of leukemia to be featured in two oral sessions at ASH

- Exjade results at ASH to show benefits for chronically transfused patients by significantly reducing toxic iron that can damage key organs

- New long-term data from major independent breast cancer trial at SABCS to report on optimal post-surgery treatment strategy, Femara vs. tamoxifen

- Multiple Zometa studies at SABCS to affirm anti-cancer activity in patients with early-stage breast cancer

EAST HANOVER, N.J., Dec. 4 /PRNewswire/ -- More than 200 abstracts from therapies across the Novartis Oncology portfolio will be presented at two December medical congresses, providing new data and profiling potential patient benefits from ongoing collaboration with the oncology community.

The American Society of Hematology (ASH) annual meeting, beginning December 6th in San Francisco, CA, will feature 34 oral presentations on the Novartis Oncology portfolio including 20 on Gleevec(R) (imatinib mesylate) tablets, six on Tasigna(R) (nilotinib) capsules, five on Exjade(R) (deferasirox) and three on products in development. The CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), beginning December 10th, will feature four oral presentations, including three on Femara(R) (letrozole tablets) and one on Zometa(R) (zoledronic acid) injection.

"Our robust portfolio and dedication to oncology research is ultimately about providing patients and their physicians with new treatment options to address unmet medical needs," said David Epstein, CEO and President of Novartis Oncology. "We are pleased that our ongoing work with experts in the fields of oncology and hematology continue to provide valuable new insights across multiple cancer types."

The most significant presentations at ASH include:

  • Tasigna data showing its benefit in the first-line treatment setting for patients with chronic myeloid leukemia, in two oral presentations (ASH Abstracts #181 & 446; Monday, December 8, 2008; 7:00 AM PST & 1:45 PM PST, respectively)
  • Cardiac data from the landmark EPIC trial, demonstrating significant benefit with Exjade in patients with transfusion-dependent anemias (ASH Abstract #3873; Monday, December 8, 2008; 5:30 PM PST). More than ten additional abstracts from the EPIC trial in patients with different underlying anemias will also be presented
  • RAD001 data demonstrating benefit in patients with relapsed and/or refractory Waldenstrom Macroglobulinemia(ASH Abstract #1011; Saturday, December 6, 2008; 5:30 - 7:30 PM PST)
  • More than 10 abstracts on panobinostat (LBH589), showing early activity across a broad range of cancers, including acute myeloid leukemia, cutaneous t-cell lymphoma, multiple myeloma and mantle cell lymphoma

The most significant presentations at the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) will include:

  • New data, presented in an oral session, from major international BIG 1-98 trial evaluating Femara vs. tamoxifen and the sequencing of the two therapies show evidence of optimal treatment strategy for postmenopausal women with breast cancer (SABCS Abstract #13; Thursday, December 11, 2008; 9:45 - 10:00 AM CST)
  • The addition of zoledronic acid to neoadjuvant chemotherapy may influence pathological response - exploratory evidence for direct anti-tumor activity in breast cancer (AZURE subgroup analysis) (SABCS Abstract #5101; Saturday, December 13, 2008; 5:00 - 7:00 PM CST). A total of nine Zometa abstracts, of which six will show the potential anti-cancer benefits of the therapy
  • The latest RAD001 data, including six abstracts, and supporting the need for additional studies to determine its potential role in the treatment of breast cancer

Other highlights of data to be presented at ASH include:


  • A Phase III, Randomized, Open-Label Study of 400 Mg Versus 800 Mg of Imatinib Mesylate in Patients with Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Using Molecular Endpoints: 1-Year Results of TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity) Study (ASH Abstract #335: Monday, December 8, 2008; 12:00 PM PST)
  • International Randomized Study of Interferon Versus STI571 (IRIS) 7-Year Follow-up: Sustained Survival, Low Rate of Transformation and Increased Rate of Major Molecular Response in Patients with Newly Diagnosed CML-CP Treated with Imatinib (ASH Abstract #186: Monday, December 8, 2008; 8:15 AM PST)


  • Efficacy and Safety of Deferasirox (Exjade(R)) in Patients with Transfusion-Dependent Anemias: 1-Year Results from the Large, Prospective, Multicenter EPIC Study (ASH Abstract #3875:Monday, December 8, 2008; 5:00 PM PST)
  • Efficacy and Safety of Deferasirox (Exjade(R)) during 1 Year of Treatment in Transfusion-Dependent Patients with Myelodysplastic Syndromes: Results from EPIC Trial (ASH Abstract #633: Monday, December 8, 2008; 3:30 PM PST)

LBH589 (panobinostat)

  • Phase II trial of Oral Panobinostat (LBH589) in Patients with Refractory Cutaneous T-Cell Lymphoma (ASH Abstract #1005: Saturday, December 6, 2008; 5:30 PM PST)
  • Phase IA/II Study of Oral Panobinostat (LBH589), a Novel Pan-Deacetylase Inhibitor (DACi) Demonstrating Efficacy in Patients with Advanced Hematologic Malignancies (ASH Abstract #958: Saturday, December 6, 2008; 5:30 PM PST)
  • A Phase II Study of Oral Panobinostat (LBH589) in Adult Patients with Advanced Refractory Multiple Myeloma (ASH Abstract #2774: Sunday, December 7, 2008; 6:00 PM PST)

Other highlights of data to be presented at SABCS include:


  • Multicenter Phase I clinical trial of daily and weekly RAD001 (everolimus) in combination with vinorelbine and trastuzumab in HER-2-overexpressing metastatic breast cancer with prior resistance to trastuzumab (SABCSAbstract #406: Friday, December 12, 2008; 7:00 - 9:00 AM CST)
  • RAD001 (everolimus) in combination with weekly paclitaxel and trastuzumab in patients with HER-2-overexpressing metastatic breast cancer with prior resistance to trastuzumab: a multicenter Phase I clinical trial (SABCSAbstract #3119: Friday, December 12, 2008; 5:00 - 7:00 PM CST)

About Gleevec

Gleevec(R) (imatinib mesylate) tablets are indicated for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in the chronic phase. Follow-up is limited to 5 years. Gleevec is also indicated for patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in the chronic phase (CP) after failure of interferon-alpha therapy.

Fetal harm can occur when administered to a pregnant woman; therefore, women of childbearing potential should be advised to not become pregnant while taking Gleevec tablets and to avoid breast-feeding while taking Gleevec tablets because of the potential for serious adverse reactions in nursing infants. Sexually active female patients taking Gleevec should use adequate contraception. If the patient does become pregnant while taking Gleevec, the patient should be advised of the potential hazard to the fetus.

Severe (NCI Grades 3/4) lab abnormalities -- including neutropenia (3.6%-48%), anemia (1%-42%), thrombocytopenia (<1%-33%) and hepatotoxicity (approx 5%) -- and severe adverse experiences (NCI Grades 3/4), including severe fluid retention (e.g., pleural effusion, pulmonary edema and ascites) and superficial edema (1.3%-11%), hemorrhage (1.8%-19%) and musculoskeletal pain (2%-9%) were reported among patients receiving Gleevec*. Severe fluid retention appears to be dose-related, was more common in the advanced phase studies (where the dosage was 600 mg/day), and is more common in the elderly.

Severe congestive heart failure and left ventricular dysfunction have occasionally been reported. Most of the patients with reported cardiac events have had other co-morbidities and risk factors, including advanced age and previous medical history of cardiac disease. Patients with cardiac disease or risk factors for cardiac failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac failure should be evaluated and treated.

Dose adjustments may be necessary due to hepatotoxicity, other nonhematologic adverse reactions, or hematologic adverse reactions. Therapy with Gleevec was discontinued for drug-related adverse reactions in 2.4% to 5% of patients. Complete blood counts should be performed weekly for the first month, biweekly for the second month, and periodically thereafter as clinically indicated (for example, every 2-3 months).

A 25% decrease in the recommended dose should be used for patients with severe hepatic impairment. Patients with moderate renal impairment (CrCL = 20-39 mL/min) should receive a 50% decrease in the recommended starting dose and increased as tolerated. Doses greater than 600 mg are not recommended in patients with mild renal impairment (CrCL = 40-59 mL/min). For patients with moderate renal impairment doses greater than 400 mg are not recommended. Gleevec should be used with caution in patients with severe renal impairment.

Patients should be weighed and monitored regularly for signs and symptoms of edema, which can be serious or life-threatening. There have also been reports, including fatalities, of cardiac tamponade, cerebral edema, acute respiratory failure and GI perforation.

Bullous dermatologic reactions (e.g., erythema multiforme and Stevens-Johnson syndrome) have also been reported. In some cases, the reaction recurred upon re-challenge. Several post-marketing reports describe patients able to tolerate the reintroduction of Gleevec at a lower dose with or without concomitant corticosteroids or antihistamines following resolution or improvement of the bullous reaction.

Consider potential toxicities--specifically liver, kidney and cardiac toxicity, and immunosuppression from long-term use.

Gleevec is metabolized by the CYP3A4 isoenzyme and is an inhibitor of CYP3A4, CYP2D6 and CYP2C9. Dosage of Gleevec should increase by at least 50%, and clinical response should be carefully monitored in patients receiving Gleevec with a potent CYP3A4 inducer such as rifampin or phenytoin. Examples of commonly used drugs that may significantly interact with Gleevec include ketoconazole, acetaminophen, warfarin, erythromycin and phenytoin. (Please see full Prescribing Information for other potential drug interactions.)

For daily dosing of 800 mg and above, dosing should be accomplished using the 400 mg tablet to reduce exposure to iron.

Common side effects of Gleevec tablets

The majority of adult Ph+ CML patients who received Gleevec in clinical studies experienced adverse reactions at some time, but most were mild to moderate in severity. The most frequently reported adverse reactions (all Grades) were superficial edema (60%-74%), nausea (50%-73%), muscle cramps (28%-62%), vomiting (23%-58%), diarrhea (43%-57%), musculoskeletal pain (38%-49%) and rash and related terms (36%-47%)*(A).

Supportive care may help management of some mild-to-moderate adverse reactions so that the prescribed dose can be maintained whenever possible. However, in some cases, either a dose reduction or interruption of treatment with Gleevec may be necessary.

Gleevec tablets should be taken with food and a large glass of water to minimize GI irritation. Gleevec tablets should not be taken with grapefruit juice and other foods known to inhibit CYP3A4.

Patients should be informed to take Gleevec exactly as prescribed, not to change their dose or stop taking Gleevec unless they are told to do so by their doctor. If patients miss a dose, they should be advised to take their dose as soon as possible unless it is almost time for their next dose, in which case the missed dose should not be taken. A double dose should not be taken to make up for any missed dose.

*Numbers indicate the range of percentages in 4 studies among adult patients, with newly diagnosed Ph+ CML, patients in blast crisis, accelerated phase and in the chronic phase after failure of interferon-alpha therapy.

(A) For more detailed study information please see full Prescribing Information.

About Tasigna

Tasigna(R) (nilotinib) capsules are indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib. The effectiveness of Tasigna is based on hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.

Warning: QT Prolongation and Sudden Deaths

Tasigna prolongs the QT interval. Sudden deaths have been reported in patients receiving nilotinib. 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 the QT interval and strong CYP3A4 inhibitors should be avoided. Patients should avoid food 2 hours before and 1 hour after taking dose. Use with caution in patients with hepatic impairment. ECGs should be obtained to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, as well as following any dose adjustments.


Treatment with Tasigna is associated with Grade 3/4 neutropenia, thrombocytopenia and anemia. Complete blood counts should be performed every 2 weeks for the first 2 months, then monthly thereafter as clinically indicated. Myelosuppression with Tasigna was generally reversible and usually managed by withholding Tasigna temporarily or dose reduction.

QT prolongation

Tasigna prolongs the QT interval. Correct hypokalemia or hypomagnesemia prior to administration and monitor periodically. Avoid drugs known to prolong the QT interval and strong CYP3A4 inhibitors. Use caution in patients with hepatic impairment. Obtain ECGs at baseline, seven days after initiation, and periodically thereafter, as well as following any dose adjustments.

Sudden deaths

There were sudden deaths reported in the safety population and the expanded access program. Ventricular repolarization abnormalities may have contributed to their occurrence.

Elevated serum lipase

Caution is recommended in patients with history of pancreatitis. Check serum lipase periodically.

Liver function abnormality

Serum bilirubin and hepatic transaminases

The use of Tasigna may result in elevations in bilirubin, AST/ALT and alkaline phosphatase. Check hepatic function tests periodically.

Electrolyte abnormalities

Tasigna can cause hypophosphatemia, hypokalemia, hyperkalemia, hyponatremia and hypocalcemia. Correct electrolyte abnormalities prior to initiating Tasigna and monitor periodically during therapy.

Hepatic impairment

Metabolism of Tasigna is mainly hepatic. Tasigna has not been investigated in patients with hepatic impairment. Caution is recommended in these patients and QT interval should be monitored closely.

Drug interactions

The concomitant use of QT prolonging drugs and strong inhibitors or inducers of CYP3A4 should be avoided as they may affect serum concentration of Tasigna.

Concomitant strong CYP3A4 inhibitors

The concomitant use of strong CYP3A4 inhibitors should be avoided (including, but not limited to, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole). Should treatment with any of these agents be required, it is recommended that therapy with Tasigna be interrupted. If interruption of treatment with Tasigna is not possible, patients who require treatment with a drug that prolongs QT or strongly inhibits CYP3A4 should be closely monitored for prolongation of the QT interval, and a dose reduction to 1/2 the daily dose is recommended (400 mg once daily). If the strong inhibitor is discontinued, a washout period should be allowed before Tasigna is adjusted upward to the indicated dose. Close monitoring for prolongation of the QT interval is indicated for patients who cannot avoid strong CYP3A4 inhibitors. Grapefruit products and other foods that are known to inhibit CYP3A4 should also be avoided.

Concomitant strong CYP3A4 inducers

The concomitant use of strong CYP3A4 inducers should be avoided (including, but not limited to, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital). Patients should also refrain from taking St John's Wort. If patients must be co-administered a strong CYP3A4 inducer, the dose of Tasigna may need to be increased, depending on patient tolerability. If the strong inducer is discontinued, the Tasigna dose should be reduced to the indicated dose. Tasigna is a competitive inhibitor of CYP3A4, CYP2C8, CYP2C9, CYP2D6 and UGT1A1. Since warfarin is metabolized by CYP2C9 and CYP3A4, it should be avoided if possible. Tasigna inhibits human P-glycoprotein. If Tasigna is administered with drugs that are substrates of Pgp, increased concentrations of the substrate are likely and caution should be exercised. Tasigna may also induce CYP2B6, CYP2C8 and CYP2C9. Therefore, Tasigna may alter serum concentration of other drugs.

Food effects

Food increases blood levels of Tasigna. Patients should avoid food 2 hours before and 1 hour after taking dose.


Since the capsules contain lactose, Tasigna is not recommended for patients with rare hereditary problems of galactose intolerance, severe lactase deficiency, or of glucose-galactose malabsorption.


Fetal harm can occur when Tasigna is administered to a pregnant woman. Women should be advised not to become pregnant when taking Tasigna.

Adverse reactions

In chronic phase patients, the most commonly reported adverse reactions (>10%) were rash (33%), pruritus (29%), nausea (31%), fatigue (28%), headache (31%), constipation (21%), diarrhea (22%) and vomiting (21%). The most common (>10%) Grade 3/4 adverse reactions were thrombocytopenia (28%), neutropenia (28%), elevated lipase (15%) and hyperglycemia (11%). In accelerated phase patients, the most commonly reported adverse reactions (>10%) were rash (28%), pruritus (20%) and constipation (18%). The most common (>10%) Grade 3/4 adverse reactions were thrombocytopenia (37%), neutropenia (37%), anemia (23%) and elevated lipase (17%). Other serious adverse reactions included pneumonia, febrile neutropenia, leukopenia, intracranial hemorrhage and pyrexia (Grade 3/4: 2%).

Dose adjustments or modifications

Tasigna may need to be temporarily withheld and/or dose reduced for QT prolongation, hematological toxicities that are not related to underlying leukemia, clinically significant moderate or severe nonhematologic toxicities, laboratory abnormalities, or concomitant use of strong CYP3A4 inhibitors. With concomitant use of strong CYP3A4 inducers, the dose of Tasigna may need to be increased, depending on patient tolerability.

Other patients in whom Tasigna should be used with caution

Tasigna should not be used during pregnancy. Sexually active female patients should use effective contraception during treatment. Women should not breast feed while taking Tasigna. There are no data to support the use of Tasigna in pediatric patients. Use with caution in patients with hepatic impairment.

Please see full Prescribing Information.

About Exjade

Exjade(R) (deferasirox) is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. Further studies are being performed to determine the long-term benefits and risks of Exjade.

Exjade is contraindicated in patients with hypersensitivity to deferasirox or to any other component of Exjade.

Cases of acute renal failure, some with a fatal outcome, have been reported following the post-marketing use of Exjade. Most of the fatalities occurred in patients with multiple comorbidities and who were in advanced stages of their hematologic disorders. There have also been reports of renal tubulopathy in patients treated with Exjade. Give particular attention to monitoring serum creatinine in patients who: are at increased risk of complications, have pre-existing renal conditions, are elderly, have comorbid conditions, or are receiving medicinal products that depress renal function.

Assess serum creatinine in duplicate before initiating therapy to establish a reliable pretreatment baseline, due to variations in measurements. Monitor serum creatinine monthly thereafter. In patients with additional renal risk factors (those who are at increased risk of complications, have pre-existing renal conditions, are elderly, have comorbid conditions, or are receiving medicinal products that depress renal function), monitor serum creatinine weekly during the first month after initiation or modification of therapy and monthly thereafter. Nonprogressive increases in serum creatinine have been noted in 38% of Exjade-treated patients, compared to 14% of deferoxamine-treated patients in Study 1 and 36% vs 22%, respectively in Study 3, and appear to be dose related. These increases were within the normal range in 94% of patients. Exjade dosages were adjusted when serum creatinine elevations were detected during the study.

Consider dose reduction, interruption, or discontinuation for elevations in serum creatinine. For adult patients, reduce daily dose of Exjade by 10 mg/kg if rise in serum creatinine to > 33% above average of the pretreatment measurements is seen at 2 consecutive visits, and cannot be attributed to other causes. For pediatric patients, reduce dose by 10 mg/kg if serum creatinine levels rise above age-appropriate upper limit of normal at 2 consecutive visits. If there is a progressive increase in serum creatinine beyond the age-appropriate upper limit of normal, interrupt Exjade use. Once the creatinine has returned to within the normal range, therapy with Exjade may be reinitiated at a lower dose followed by gradual dose escalation, if the clinical benefit is expected to outweigh potential risks.

Intermittent proteinuria (urine protein/creatinine ratio >0.6 mg/mg) occurred in 18.6% of Exjade-treated patients, compared to 7.2% of deferoxamine-treated patients in Study 1, and monthly monitoring is recommended.

There have been post-marketing reports of cytopenias (including agranulocytosis, neutropenia and thrombocytopenia) in patients treated with Exjade. Some of these patients died. The relationship of these episodes to treatment with Exjade is uncertain. Most of these patients had pre-existing hematologic disorders that are frequently associated with bone marrow failure. In line with standard clinical management, monitor blood counts regularly. Consider interrupting treatment with Exjade in patients who develop unexplained cytopenia. Reintroduction of therapy with Exjade may be considered once the cause of the cytopenia has been elucidated.

There have been post-marketing reports of hepatic failure, some with a fatal outcome, in patients treated with Exjade. Most of these events occurred in patients greater than 55 years of age. Most reports of hepatic failure involved patients with significant comorbidities, including liver cirrhosis and multi-organ failure. Monitor liver function tests monthly during Exjade treatment and consider dose modifications or interruption for severe or persistent elevations. In Study 1, seventeen (5.7%) patients treated with Exjade developed elevations in SGPT/ALT levels >5 times the upper limit of normal at 2 consecutive visits versus five (1.7%) patients treated with deferoxamine.

Serious hypersensitivity reactions (such as anaphylaxis and angioedema) have been reported in patients receiving Exjade, with the onset of the reaction occurring in the majority of cases within the first month of treatment. If reactions are severe, discontinue Exjade and institute appropriate medical intervention.

Skin rashes may occur during treatment with Exjade. For rashes of mild to moderate severity, Exjade may be continued without dose adjustment, since the rash often resolves spontaneously. In severe cases, Exjade may be interrupted. Reintroduction at a lower dose with escalation may be considered in combination with a short period of oral steroid administration.

Auditory (high-frequency hearing loss, decreased hearing) and ocular (lens opacities, cataracts, elevations in intraocular pressure and retinal disorders) disturbances have been reported with Exjade therapy in less than 1% of patients in clinical trials. Auditory and ophthalmic testing (including slit lamp examinations and dilated fundoscopy) are recommended before the start of Exjade treatment and thereafter at regular intervals (every 12 months). If disturbances are noted, consider dose reduction or interruption.

Gastrointestinal (GI) irritation may occur during Exjade treatment. Upper GI ulceration and hemorrhage have been reported in patients, including children and adolescents, receiving Exjade. Physicians and patients should remain alert for signs and symptoms of GI ulceration and hemorrhage and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. Use caution when administering Exjade in combination with drugs that have ulcerogenic or hemorrhagic potential, such as non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, oral bisphosphonates or anticoagulants.

The most frequently occurring adverse reactions with a suspected relationship to Exjade were diarrhea, vomiting, nausea, abdominal pain, skin rash and increases in serum creatinine. Maintenance of adequate hydration for patients experiencing diarrhea or vomiting is recommended. Gastrointestinal symptoms, increases in serum creatinine and skin rash were dose related. These commonly reported adverse events were predominantly mild to moderate in severity with serious adverse events reported in 9.1% of patients in the Exjade arm and 8.6% of patients in the deferoxamine arm.

For full prescribing information, please visit

About Femara

Femara(R) (letrozole tablets) is approved for the adjuvant (following surgery) treatment of postmenopausal women with hormone receptor-positive early stage breast cancer. The benefits of Femara in clinical trials are based on 24 months of treatment. Further follow-up will be needed to determine long-term results, safety and efficacy.

Femara is also approved for the extended adjuvant treatment of early stage breast cancer in postmenopausal women who are within three months of completion of five years of tamoxifen therapy. The benefits of Femara in clinical trial are based on 24 months of treatment. Further follow-up will be needed to determine long-term results, including side effects.

In addition, Femara is approved for the treatment of postmenopausal women with estrogen receptor-positive or estrogen receptor-unknown breast cancer that has spread to another part of the body (metastatic cancer).

You should not take Femara if you are premenopausal. Your doctor should discuss the need for adequate birth control if you have the potential to become pregnant, if you are not sure of your postmenopausal status, or if you recently became postmenopausal. Femara is only indicated in postmenopausal women. Talk to your doctor if you're allergic to Femara or any of its ingredients. You should not take Femara if you are pregnant, as it may cause fetal harm. Some women reported fatigue and dizziness with Femara. Until you know how it affects you, use caution before driving or operating machinery. Some patients taking Femara had an increase in cholesterol. Additional follow-up is needed to determine the risk of bone fracture associated with long-term use of Femara.

In the adjuvant setting, commonly reported side effects are generally mild to moderate. The most common side effects seen with Femara include hot flashes, joint pain, night sweats, weight gain, nausea, tiredness, other heart-related events and bone fractures. Other less commonly reported side effects include vaginal bleeding, blood clots, other cancers, osteoporosis, stroke, heart attack and endometrial cancer.

In the extended adjuvant setting, commonly reported side effects are generally mild to moderate. Commonly reported side effects for Femara include hot flashes, fatigue, joint pain, headache, increase in sweating, swelling due to fluid retention, increase in cholesterol, dizziness, constipation, nausea, cardiovascular ischemic events, muscle pain, osteoporosis, arthritis and bone fracture.

In the metastatic cancer setting, commonly reported side effects are generally mild to moderate and may include bone pain, hot flashes, back pain, nausea, joint pain, shortness of breath, tiredness, coughing, constipation, limb pain, chest pain and headache.

About Zometa

Zometa(R) (zoledronic acid) is indicated for patients with multiple myeloma and documented bone metastases from solid tumors in conjunction with standard antineoplastic therapy; prostate cancer should have progressed after treatment with at least one hormonal therapy.

Zometa is contraindicated in patients with hypersensitivity to zoledronic acid or other bisphosphonates, or any of the excipients in the formulation of Zometa. Hypersensitivity reactions, including rare cases of urticaria and angioedema and very rare cases of anaphylactic reaction/shock, have been reported.

Due to the risk of clinically significant deterioration in renal function, which may progress to renal failure, single doses of Zometa should not exceed 4 mg, and the duration of infusion should be no less than 15 minutes. Risk factors for the deterioration of renal function include impaired baseline renal function and multiple cycles of bisphosphonate treatment.

Zometa is not recommended in patients with bone metastases with severe renal impairment. In patients with mild to moderate renal impairment at baseline, lower doses of Zometa are recommended based on calculated creatinine clearance. Before each Zometa dose, serum creatinine should be measured and treatment should be withheld for renal deterioration until serum creatinine has returned to within 10% of the baseline value.

Zometa should not be used during pregnancy. Women of childbearing potential should be advised to avoid becoming pregnant. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Osteonecrosis of the jaw (ONJ) has been reported predominantly in cancer patients treated with intravenous bisphosphonates, including Zometa. Many of these patients were also receiving chemotherapy and corticosteroids, which may be risk factors for ONJ. Post-marketing experience and the literature suggest a greater frequency of reports of ONJ based on tumor type (advanced breast cancer, multiple myeloma) and dental status (dental extraction, periodontal disease, local trauma, including poorly fitting dentures). Many reports of ONJ involved patients with signs of local infection, including osteomyelitis. Cancer patients should maintain good oral hygiene and should have a dental examination with preventive dentistry prior to treatment with bisphosphonates. While on treatment, these patients should avoid invasive dental procedures, if possible. No data are available as to whether discontinuation of bisphosphonate therapy reduces the risk of ONJ in patients requiring dental procedures. A causal relationship between bisphosphonate use and ONJ has not been established. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.

In post-marketing experience, severe and occasionally incapacitating bone, joint and/or muscle pain has been reported infrequently in patients taking bisphosphonates.

The most common adverse events (greater than or equal to 15%) in bone metastases clinical trials, regardless of causality, with Zometa 4 mg (n=1031) were as follows: bone pain (55%), nausea (46%), fatigue (39%), anemia (33%), pyrexia (32%), vomiting (32%), constipation (31%), dyspnea (27%), diarrhea (24%), weakness (24%), myalgia (23%), anorexia (22%), cough (22%), arthralgia (21%), lower-limb edema (21%), malignant neoplasm aggravated (20%), headache (19%), dizziness (excluding vertigo) (18%), insomnia (16%), decreased weight (16%), back pain (15%) and paresthesia (15%).

Caution is advised when bisphosphonates are administered with aminoglycosides, loop diuretics and potentially nephrotoxic drugs.

Zometa contains the same active ingredient as found in Reclast(R) (zoledronic acid). Patients being treated with Zometa should not be treated with Reclast.

Patients should be administered an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of vitamin D daily.

Please see full Prescribing Information.

About RAD001

RAD001, an oral once-daily inhibitor of mTOR, is an investigational drug being studied in multiple tumor types. In cancer cells, RAD001 provides continuous inhibition of mTOR, a protein that acts as a central regulator of tumor cell division, cell metabolism and blood vessel growth.

The safety and efficacy profile of RAD001 has not yet been established in oncologyand there is no guarantee that RAD001 will become commercially available for oncology indications. The active ingredient in RAD001 is everolimus, which is available in different dosage strengths under the trade name Certican(R) for the prevention of organ rejection in heart and kidney transplant recipients. Certican was first approved in the EU in 2003.

RAD001 is being evaluated as a single agent or in combination with existing therapies for renal cell carcinoma, neuroendocrine tumors, lymphoma, breast, gastric, lung and other cancers, as well as tuberous sclerosis.

About LBH589 (panobinostat)

Panobinostat (LBH589), is an investigational pan-deacetylase (DAC) inhibitor which interferes with many of the pathophysiological mechanisms involved in cancer. Specifically, panobinostat causes an increased acetylation of both histone and non-histone proteins which are implicated in oncogenesis and thereby modulates their activity. In this way, panobinostat selectively induces the death of tumor cells. To date, objective clinical responses in patients with hematologic and solid malignancies have been observed with panobinostat.


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About Novartis Pharmaceuticals Corporation

Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, GI and respiratory areas. 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 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, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools, and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group's continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 97,000 full-time associates and operate in over 140 countries around the world. For more information, please visit

    Novartis Media Relations

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    Geoffrey Cook         Jill Pozarek
    Novartis Oncology     Novartis Corporation
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    Dana Kahn Cooper
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