FDA Advisory Committee Votes Against Recommendation for Approval of Two Cancer Medications
An FDA advisory committee on Monday decided not to recommend approval for Genasense, an advanced malignant melanoma medication developed by New Jersey-based Genta and French partner Aventis, and RSR13, a treatment for breast cancer patients whose disease has spread to their brains developed by Colorado-based Allos Therapeutics, the Wall Street Journal reports. In a 771-participant clinical trial, Genasense, combined with chemotherapy, failed to extend the lives of melanoma patients, the main target of the trial, but Genta officials said that the medication helped reduce tumor size and delayed the progress of the disease (Wilde Mathews, Wall Street Journal, 5/4). Genta officials said that among trial participants who received Genasense, the median time before their melanoma worsened was 74 days, compared with 49 days for those who received only chemotherapy (Pollack, New York Times, 5/4). However, the advisory committee voted 13-3 not to recommend approval of Genasense over concerns that Genta may have "skewed the findings" of the trial when they measured the results and "hadn't shown enough evidence that benefits outweighed potential risks to patients," the Journal reports (Wall Street Journal, 5/4). Genta officials said that the company would continue the development of Genasense, adding that phase III trials that involve patients with chronic lymphocytic leukemia and multiple myeloma remain in progress (Stark, Philadelphia Inquirer, 5/4).
The advisory committee also voted 16-1 not to recommend approval for RSR13, which Allos developed to make radiation therapy more effective. In a trial, Allos researchers tested RSR13 in patients who received radiation for tumors that had spread to the brain from other parts of the body (New York Times, 5/4). In the application submitted to FDA, Allos focused on the results among 115 breast cancer patients who participated in the trial; breast cancer patients who received RSR13 lived an average of 4.1 months longer than those who did not receive the medication (Wall Street Journal, 5/4). However, the advisory committee said that the "finding could be spurious because the company had not defined this subset of patients in advance," the Times reports. Allos has begun a trial that involves only breast cancer patients (New York Times, 5/4).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.