Medication Guide App

Sanofi Showcases Commitment to Prostate Cancer Research at Genitourinary Cancer Symposium

Bridgewater, NJ – February 12, 2013 – Sanofi US today announced that ten company-supported abstracts covering ongoing prostate cancer research will be presented on February 14 and 15 during the 2013 Genitourinary Cancers Symposium in Orlando, FL. Major sponsors of the Symposium are the American Society of Clinical Oncology (ASCO), American Society of Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO).

Abstracts to be presented during General Poster Session A on Thursday, February 14 from 11:45 am – 1:15 pm and 5:05 pm – 6:35 pm at Rose Shingle Creek (Gatlin Ballroom B), 9939 University Blvd. are:

• Abstract #24: A model for predicting overall survival in men with metastatic castrate-resistant prostate cancer for whom first-line chemotherapy failed (B15)

Susan Halabi - Duke University Medical Center

• Abstract #44: The initial biopsy Gleason score as a predictive marker for docetaxel survival benefit in patients with prostate cancer: Data from the TAX 327 study (C17)

Robert van Soest - Erasmus University Medical Center

• Abstract #66: Association of radical prostate cancer therapy with a survival benefit in the older man (E3)

Paul Cathcart - University College Hospital London

• Abstract #79: Sequencing of cabazitaxel and abiraterone acetate following docetaxel in metastatic castration-resistant prostate cancer (E16)

Ian D. Schnadig - Compass Oncology, McKessson Specialty Health

• Abstract #91: Cabazitaxel for metastatic castration-resistant prostate cancer: Final quality-of-life  results with safety data from the United Kingdom Early Access Programme (NCT01254279) (F10)

Amit Bahl - Bristol Haematology and Oncology Centre

• Abstract #122: Retrospective registry evaluating the PSA flare phenomenon with cabazitaxel in metastatic castration-resistant prostate cancer (H5)

Antoine Angelergues - Department of Medical Oncology, Georges Pompidou European Hospital

• Abstract #126: Absence of interaction of cabazitaxel on the pharmacokinetics of midazolam: Results of a drug–drug interaction study in patients with advanced solid tumors (H9)

Olivier Rixe - Georgia Health Sciences University

• Abstract #137: Efficacy of cabazitaxel and its relationship with predictors of poor response to second hormonal therapies in metastatic castration-resistant prostate cancer (J2)

Stephane Oudard - Department of Medical Oncology, Georges Pompidou European Hospital

Abstracts to be presented during General Poster Session B on Friday, February 15 from 12:15 pm – 1:45 pm and 5:15 pm – 6:45 pm at Rose Shingle Creek (Gatlin Ballroom B), 9939 University Blvd are:

 

• Abstract #189: Which data for cabazitaxel from the real world? The safety experience from the Italian centres participating in the Expanded Access Programme (B13)

Sergio Bracarda - Department of Oncology, USL-8, Ospedale San Donato

• Abstract #224: Cabazitaxel in patients with metastatic castrate-resistant prostate cancer previously treated with a docetaxel-containing regimen: A single U.K. cancer center's experience using Early Access Programme and Cancer Drugs Fund (D12)

Claire L. S. Kelly - Rosemere Cancer Centre, Royal Preston Hospital

About Jevtana® (cabazitaxel) Injection

Jevtana is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen. Jevtana has been shown to work by causing the intracellular microtubules, which help separate chromosomes into daughter cells during cell division, to stabilize so that the cells can no longer grow or divide. Jevtana is currently approved in more than 60 countries, including the member states of the EU, the US, and Brazil.

Important Safety Information for Jevtana®

WARNING: NEUTROPENIA AND HYPERSENSITIVITY

Neutropenic deaths have been reported. In order to monitor the occurrence of neutropenia, frequent blood cell counts should be performed on all patients receiving JEVTANA. JEVTANA should not be given to patients with neutrophil counts of ≤1,500 cells/mm3

Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm. Severe hypersensitivity reactions require immediate discontinuation of the JEVTANA infusion and administration of appropriate therapy. Patients should receive premedication

JEVTANA must not be given to patients who have a history of severe hypersensitivity reactions to JEVTANA or to other drugs formulated with polysorbate 80

CONTRAINDICATIONS

• JEVTANA should not be used in patients with neutrophil counts of ≤1,500/mm3

• JEVTANA is contraindicated in patients who have a history of severe hypersensitivity reactions to JEVTANA or to other drugs formulated with polysorbate 80

 

WARNINGS AND PRECAUTIONS

• Neutropenic deaths have been reported

o Monitoring of complete blood counts is essential on a weekly basis during cycle 1 and before each treatment cycle thereafter so that the dose can be adjusted, if needed

o Monitor blood counts frequently to determine if initiation of G-CSF and/or dosage modification is needed

o Primary prophylaxis with G-CSF should be considered in patients with high-risk clinical features

• Severe hypersensitivity reactions can occur

o Premedicate with antihistamines, corticosteroids and H2 antagonists

o Patients should be observed closely for hypersensitivity reactions, especially during the first and second infusions

o Discontinue infusion immediately if hypersensitivity is observed and treat as indicated

• Mortality related to diarrhea has been reported

o Rehydrate and treat with anti-emetics and anti-diarrheals as needed

o If experiencing grade ≥3 diarrhea, dosage should be modified

• Nausea, vomiting and severe diarrhea, at times, may occur. Death related to diarrhea and electrolyte imbalance occurred in the randomized clinical trial. Intensive measure may be required for severe diarrhea and electrolyte imbalance.

• Renal failure, including cases with fatal outcomes, has been reported. Identify cause and manage aggressively

• Patients ≥65 years of age were more likely to experience fatal outcomes not related to disease progression and certain adverse reactions, including neutropenia and febrile neutropenia. Monitor closely

• Patients with impaired hepatic function were excluded from the randomized clinical trial

o Hepatic impairment is likely to increase the JEVTANA concentrations

o JEVTANA should not be given to patients with hepatic impairment

• JEVTANA can cause fetal harm when administered to a pregnant woman

o There are no adequate and well-controlled studies in pregnant women using JEVTANA

o Women of childbearing potential should be advised to avoid becoming pregnant during treatment with JEVTANA

ADVERSE REACTIONS

• Deaths due to causes other than disease progression within 30 days of last study drug dose were reported in 18 (5%) JEVTANA-treated patients. The most common fatal adverse reactions in JEVTANA-treated patients were infections (n=5) and renal failure (n=4)

• The most common (≥10%) grade 1–4 adverse reactions were anemia, leukopenia, neutropenia, thrombocytopenia, diarrhea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysgeusia, cough, arthralgia, and alopecia

• The most common (≥5%) grade 3–4 adverse reactions in patients who received JEVTANA were neutropenia, leukopenia, anemia, febrile neutropenia, diarrhea, fatigue, and asthenia

Please click here or see accompanying full Prescribing Information for Jevtana® (cabazitaxel) Injection, including Boxed WARNING and visit www.jevtana.com.

About Taxotere® (docetaxel) Injection Concentrate

Taxotere is a microtubule inhibitor indicated in combination with prednisone for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer.

Important Safety Information for Taxotere®

WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION

The incidence of treatment-related mortality associated with Taxotere® therapy is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive Taxotere® as a single agent at a dose of 100 mg/m2 (see WARNINGS and PRECAUTIONS section of the prescribing information)

Taxotere® should generally not be given to patients with bilirubin > upper limit of normal (ULN), or to patients with serum glutamic-oxaloacetic transaminase (SGOT) and/or serum glutamic-pyruvic transaminase (SGPT) > 1.5 X ULN concomitant with alkaline phosphatase > 2.5 X ULN

• Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of grade 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death

• Patients with isolated elevations of transaminase > 1.5 X ULN also had a higher rate of febrile neutropenia grade 4 but did not have an increased incidence of toxic death

• Bilirubin, SGOT or SGPT, and alkaline phosphatase values should be obtained prior to each cycle of Taxotere® therapy and reviewed by the treating physician

Taxotere® therapy should not be given to patients with neutrophil counts of < 1500 cells/mm3

• In order to monitor the occurrence of neutropenia, which may be severe and result in infection, frequent blood-cell counts should be performed on all patients receiving Taxotere®

Severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis, have been reported in patients who received the recommended 3-day dexamethasone premedication

• Hypersensitivity reactions require immediate discontinuation of Taxotere® infusion and administration of appropriate therapy (see WARNINGS AND PRECAUTIONS section of the prescribing information)

Taxotere® must not be given to patients who have a history of severe hypersensitivity reactions to Taxotere® or to other drugs formulated with polysorbate 80 (see CONTRAINDICATIONS section of the prescribing information)

Severe fluid retention occurred in 6.5% (6/92) of patients despite use of a 3-day dexamethasone premedication regimen. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites) (see WARNINGS and PRECAUTIONS section of the prescribing information)

• Neutropenia (<2,000 neutrophils/mm3) occurs in virtually all patients given 60-100 mg/m2 of Taxotere® and grade 4 neutropenia (<500 cells/mm3) occurs in 85% of patients given 100 mg/m2 and 75% of patients given 60 mg/m2

• Patients should be premedicated with oral corticosteroids prior to each Taxotere® administration to reduce the incidence and severity of fluid retention. Patients with pre-existing effusions should be closely monitored from the first dose for possible exacerbation of the effusions

• Localized erythema of the extremities with edema followed by desquamation has been observed

o In case of severe skin toxicity, an adjustment in dosage is recommended

• The most common adverse reactions across all Taxotere® indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions and myalgia

• Taxotere® should be administered in a facility equipped to manage possible complications (eg, anaphylaxis)

Please click here or see accompanying full prescribing information for Taxotere® (docetaxel) Injection Concentrate, including boxed WARNING and visit www.taxotere.com.

About Prostate Cancer

In the US, prostate cancer affects nearly one in every six men and is the second-leading cause of cancer-related death after lung cancer, resulting in more than 28,000 deaths annually. More than 240,000 American men were diagnosed with the disease in 2012, with an estimated 15 percent of patients diagnosed when the cancer has already metastasized to the lymph nodes or other parts of the body.

About Sanofi Oncology

Based in Cambridge, Massachusetts, USA and Vitry, France, Sanofi Oncology is dedicated to translating science into effective therapeutics that address unmet medical needs for cancer and organ transplant patients. Starting with a deep understanding of the disease and the patient, Sanofi Oncology employs innovative approaches to drug discovery and clinical development, with the ultimate goal of bringing the right medicines to the right patients to help them live healthier and longer lives. We believe in the value of partnerships that combine our internal scientific expertise with that of industry and academic experts. Our portfolio includes 11 marketed products and more than 15 investigational compounds in clinical development, including small molecules and biological agents.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi is the holding company of a consolidated group of subsidiaries and operates in the United States as Sanofi US. For more information on Sanofi US, please visit http://www.sanofi.us or call 1-800-981-2491.

Sanofi Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

 http://products.sanofi.us/Taxotere/taxotere.html

http://products.sanofi.us/Taxotere/taxotere.html

Posted: May 2013

View comments

Hide
(web2)