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| |  FDA Approves Avastin(R) (Bevacizumab) in Combination With Chemotherapy for First-Line Treatment of Most Common Type of Lung Cancer Avastin Is First Therapy to Extend Survival Beyond One Year in Patients with Advanced Non-Small Cell Lung Cancer Genentech Expands Patient Access Programs to Include Annual Expenditure Cap for Avastin – SOUTH SAN FRANCISCO, CA -- October 12, 2006 -- Genentech, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Avastin® (bevacizumab) to be used in combination with carboplatin and paclitaxel chemotherapy for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC), the most common type of lung cancer. The approval is based on a phase 3 study (E4599) that showed Avastin in combination with chemotherapy resulted in a 25% improvement in overall survival compared to chemotherapy alone (based on a hazard ratio of 0.80). "Bevacizumab, in combination with chemotherapy, is the first therapy in 10 years to improve on standard first-line treatment for advanced lung cancer and the first FDA approved therapy ever to extend survival for these patients beyond one year in a large, randomized clinical study," said Alan Sandler, MD, director of Medical Thoracic Oncology at Vanderbilt-Ingram Cancer Center in Nashville, Tenn., and lead investigator on the E4599 trial. "With this survival benefit, bevacizumab represents an important therapy for many advanced lung cancer patients fighting this difficult disease." "Lung cancer is responsible for more than one-third of all U.S. cancer deaths, killing more people than breast, prostate, colon, liver and kidney cancers combined," said Laurie Fenton, president of the Lung Cancer Alliance in Washington, D.C. "The approval of Avastin plus chemotherapy is a significant stride in the right direction, and we are pleased that Genentech continues to make lung cancer a priority." About E4599 Results showed that patients receiving Avastin plus paclitaxel and carboplatin chemotherapy had a 25% improvement in overall survival, the trial's primary endpoint, compared to patients who received paclitaxel and carboplatin alone (based on a hazard ratio of 0.80). One-year survival was 51% in the Avastin plus chemotherapy arm versus 44% in the chemotherapy-alone arm. Median survival of patients treated with Avastin plus chemotherapy was 12.3 months, compared to 10.3 months for patients treated with chemotherapy alone. The E4599 trial was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, under a Cooperative Research and Development Agreement between NCI and Genentech. The trial was conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG). E4599 Safety Analysis In Study E4599, the rate of pulmonary hemorrhage requiring medical intervention for the paclitaxel and carboplatin plus Avastin arm was 2.3% (10/427), compared to 0.5% (2/441) for the paclitaxel and carboplatin-alone arm. There were seven deaths due to pulmonary hemorrhage reported by investigators in the paclitaxel and carboplatin-plus Avastin arm, as compared to one in the paclitaxel and carboplatin alone arm. In previous clinical experience with Avastin in combination with paclitaxel and carboplatin in NSCLC, patients with a specific type of NSCLC called squamous cell carcinoma had a higher risk of experiencing life-threatening or fatal pulmonary bleeding. Squamous cells are a particular kind of cell that form in the lining of the air ducts in the lung. Because of the risk of bleeding attributed to this population, patients with NSCLC classified as predominantly squamous histology were not included in the E4599 trial. About the New Avastin Annual Expenditure Cap and Genentech's Access to Care Programs "The clinical development program that led to Avastin's three FDA approvals suggested dose and duration vary depending on tumor type," said Arthur D. Levinson, PhD, Genentech's chairman and chief executive officer. "The new expenditure cap on Avastin is a step Genentech is taking to address this variability in current and future FDA-approved indications. This new program, along with the increased contribution to independent charities that provide co-pay assistance to patients, continues our 20-year history of commitment to patient access." The price of Avastin was established in February 2004 upon the FDA approval of the drug for the treatment of first-line colorectal cancer in combination with 5-FU based chemotherapy. At that time, the monthly price of Avastin was set below the standard of care chemotherapy for metastatic colorectal cancer at approximately $4,400. In advanced lung cancer, a higher dose of Avastin is indicated. This dose was based on clinical data from a randomized dose-ranging Phase II study of Avastin in combination with chemotherapy. Based on this trial, ECOG and NCI selected the higher dose for the pivotal Phase III trial in NSCLC. The typical monthly cost of Avastin at this dose is approximately $8,800 and, based on median progression-free survival as measured in the E4599 trial, the average cost per course of therapy in NSCLC is approximately $56,000. Avastin is covered by most insurers and Medicare for its approved indications. Genentech's donation to independent co-pay charities helps provide assistance to eligible patients with higher co-pay burdens. For eligible uninsured patients, the Genentech Access to Care Foundation (GATCF) provides Avastin for free. Genentech has provided more than $850 million in free drug to patients since 1990. In 2005 alone, GATCF supported over 18,000 patients by providing approximately $200 million of free product. About Lung Cancer About Avastin The FDA first approved Avastin on February 26, 2004, as a first-line treatment for metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy. The National Comprehensive Cancer Network recommends Avastin plus chemotherapy as a standard treatment for the first- and second-line treatment of metastatic colorectal cancer and as a first-line treatment of advanced non-squamous NSCLC. Avastin Safety 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 3 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. About VEGF and Tumor Angiogenesis In 1993, in a study published in the journal Nature, Ferrara and his team demonstrated that the antibody directed against VEGF could suppress angiogenesis and tumor growth in preclinical models, providing compelling evidence that VEGF can play an important role in tumor growth. Clinical studies with a humanized version of the antibody, Avastin, began in 1997.
SOURCE: Genentech
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