Healthcare Industry News: 5-FU
News Release - February 22, 2007
Analysis of International Phase III Study of Avastin(R) Plus Chemotherapy Shows Improved Progression-Free Survival in Patients With Advanced Lung CancerSOUTH SAN FRANCISCO, Calif., Feb. 22 (HSMN NewsFeed) -- Genentech, Inc. (NYSE: DNA ) announced today that a Roche-sponsored Phase III study evaluating two different doses of Avastin® (bevacizumab) in combination with gemcitabine and cisplatin chemotherapy met the primary endpoint of prolonging progression-free survival (PFS) in patients with previously untreated, advanced non-squamous, non-small cell lung cancer (NSCLC), the most common form of the disease. Both doses of Avastin (15 mg/kg or 7.5 mg/kg every three weeks) significantly improved PFS compared to chemotherapy alone, as assessed by trial investigators. Although the study was not designed to compare the Avastin doses, a similar treatment effect in PFS was observed between the two arms. No new safety signals related to Avastin were observed in the study. More than 1,000 patients from outside of the United States participated in the trial, known as AVAiL (BO17704).
"In addition to supporting Avastin's benefit in advanced lung cancer, these results demonstrate Avastin's potential when used in combination with a different chemotherapy regimen," said Hal Barron, M.D., Genentech's senior vice president, Development and chief medical officer. "We will continue to analyze these data to better understand the benefit and relative safety of each arm and these findings will be presented at an upcoming medical meeting."
Based on an improvement in overall survival, the U.S. Food and Drug Administration (FDA) in October 2006 granted a supplemental approval for Avastin in combination with carboplatin and paclitaxel for the first-line treatment of advanced NSCLC. The U.S. approval is based on results of the Phase III E4599 trial that studied a 15 mg/kg dose of Avastin administered every three weeks. The 15 mg/kg dose was selected based on the outcome of a randomized Phase II study evaluating two different doses of Avastin in combination with carboplatin and paclitaxel chemotherapy.
About Lung Cancer
According to the American Cancer Society (ACS), lung cancer is the single largest cause of cancer death among men and women in the U.S. and is responsible for nearly 30 percent of cancer deaths each year. The ACS estimates that more than 213,000 Americans will be diagnosed with lung cancer and 160,000 Americans will die of the disease in 2007.
Avastin is a therapeutic antibody designed to specifically inhibit vascular endothelial growth factor (VEGF), a protein that plays an important role in angiogenesis and the maintenance of existing blood vessels throughout the lifecycle of a tumor. By inhibiting VEGF, Avastin is designed to interfere with the blood supply to a tumor, which is thought to be critical to a tumor's ability to grow and spread in the body (metastasize). For more information on angiogenesis, visit http://www.gene.com. For full prescribing information and Boxed Warnings on Avastin, visit http://www.avastin.com.
The FDA approved Avastin on February 26, 2004, as a first-line treatment for metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy. Avastin is also indicated in combination with intravenous 5-FU-based chemotherapy for second-line treatment of patients with metastatic carcinoma of the colon or rectum.
The most serious adverse events associated with Avastin across all trials were gastrointestinal perforation, wound healing complications, hemorrhage, arterial thromboembolic events, hypertensive crisis, reversible posterior leukoencephalopathy syndrome (RPLS), neutropenia and infection, nephrotic syndrome and congestive heart failure. The most common adverse events in patients receiving Avastin were asthenia, pain, abdominal pain, headache, hypertension, diarrhea, nausea, vomiting, anorexia, stomatitis, constipation, upper respiratory infection, epistaxis, dyspnea, exfoliative dermatitis and proteinuria.
About the Avastin Development Program
Based on data showing that VEGF may play a broad role in a range of cancers, Genentech is pursuing a broad development program for Avastin that currently includes 130 clinical trials across 25 different types of cancer. Avastin is being evaluated in Phase III clinical trials for its potential use in adjuvant and metastatic colorectal, renal cell (kidney), breast, non-small cell lung, prostate and ovarian cancers. Avastin is also being evaluated in earlier stage trials as a potential therapy in a variety of solid tumor cancers and hematologic malignancies. For further information about Avastin clinical trials, please call 888-662-6728.
About Genentech's Commitment to Patient Access
Genentech is committed to eligible patients having access to our therapies. For those eligible patients treated for approved indications in the United States who do not have insurance or who cannot afford their out-of-pocket co-pay costs, Genentech has several support programs. Since 1985, Genentech has donated free product to uninsured patients and those deemed uninsured due to payor denial through its Genentech® Access to Care Foundation (GATCF) and the Genentech Endowment for Cystic Fibrosis. In 2006 alone, GATCF supported more than 14,000 patients by providing approximately $205 million of free product. Since 2005, Genentech has donated approximately $70 million to various independent public charities that provide financial assistance to eligible patients who cannot access needed medical treatment due to co-pay costs. Through its Single Point of Contact (SPOC) program, Genentech provides patients with assistance and information on a broad array of reimbursement services and support.
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products and licenses several additional products to other companies. The company has headquarters in South San Francisco, Calif., and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.
This press release contains forward-looking statements regarding Avastin's potential as a therapy. Such statement is a prediction and involves risks and uncertainties such that actual results may differ materially. Among other things, Avastin's potential could be affected by unexpected safety, efficacy or manufacturing issues, additional time requirements for data analysis, BLA preparation or decision-making, the need for additional clinical studies, FDA actions or delays, failure to obtain or maintain FDA approval, competition, intellectual property or contract rights, the ability to supply product, product withdrawal or achieving sales revenue consistent with internal forecasts. Please also refer to Genentech's periodic reports filed with the Securities and Exchange Commission. Genentech disclaims, and does not undertake, any obligation to update or revise the forward-looking statement in this press release.
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