October 1, 2010
Avastin, the anti-cancer drug already widely used off-label by physicians to treat the wet form of age-related macular degeneration, is as effective as Lucentis, the gold standard for treatment of the disorder, researchers said Friday. The first head-to-head study of the two drugs could be a step toward Food and Drug Administration approval to market Avastin for macular degeneration, which would lead more insurance companies to reimburse patients for its use. Potentially more important, Avastin is much cheaper than Lucentis -- costing about $50 per injection compared with $2,000 per injecton for Lucentis.
August 17, 2010 |
An important but obscure aspect of the Food and Drug Administration's regulation of drugs has been in the news in recent months. Called "accelerated approval," this "quick-on, quick-off" mechanism for medicines to reach the marketplace can work to the advantage of drug companies and needy patients alike. Introduced almost two decades ago, accelerated approval permits the FDA to issue what amounts to a limited, or conditional, approval of a new drug that is intended for a "serious or life-threatening disease" and for which there is an "unmet medical need.
July 21, 2010 |
A Food and Drug Administration advisory committee Tuesday recommended that the agency withdraw its marketing approval of the blockbuster cancer drug Avastin for treating breast cancer, concluding that new trials showed no apparent benefit from the drug. The action, if taken, would not affect marketing of the drug for brain, lung, colon and kidney cancer, but would prevent the manufacturer from promoting its use for breast cancer. The agency issued a so-called accelerated approval of the drug for breast cancer on Feb. 22, 2008.
July 20, 2010 |
A Food and Drug Administration advisory committee Tuesday recommended that the agency withdraw approval of the blockbuster cancer drug Avastin for treating breast cancer. The decision would not affect the manufacturer's ability to market the drug for treating colon, lung and other cancers. Avastin contributes annual sales of about $6 billion to its manufacturer, Roche, with about a sixth of that from sales for breast cancer. When the FDA initially approved the drug for breast cancer in 2008, the agency required Roche to perform additional studies of its efficacy.
June 7, 2010 |
The cancer drug Avastin extends progression-free survival by 39% in ovarian cancer patients, a significant improvement in a cancer that has proved extremely difficult to treat. Some oncologists are already using Avastin — which is widely and successfully used for lung, colon and breast tumors — to treat ovarian cancer that has recurred, but such use has never been formally studied. The new study, reported Sunday at a Chicago meeting of the American Society of Clinical Oncology, is also the first to use the drug as first-line therapy for ovarian cancer.
December 20, 2008 |
Genentech Inc. has received 36 reports of eye inflammation in Canadian patients who were given the cancer drug Avastin to treat eye diseases. The South San Francisco company said the injuries developed when doctors used Avastin to treat macular degeneration or diabetic retinopathy. Avastin isn't approved for use in the chronic eye diseases.
November 25, 2008 |
Genentech Inc. and Roche Holding's Avastin, in combination with the most commonly used chemotherapies, helped women with breast cancer live longer without their disease worsening, a finding that could bolster use of the medicine. Avastin, used as a first-line therapy and combined with either Switzerland-based Roche's Xeloda, a taxane drug such as paclitaxel or anthracycline, kept tumors in check in women with advanced breast cancer better than chemotherapy alone, the companies said.
November 19, 2008 |
Genentech Inc.'s Avastin, widely prescribed for colon cancer and some lung tumors, was linked to significantly higher rates of vein clotting in an analysis of earlier studies. Patients who got the drug were 33% more likely to have blood clots develop in their veins than those who didn't receive it, said researchers led by Shenhong Wu, a cancer specialist at Stony Brook University in Stony Brook, N.Y. Avastin, Genentech's top-selling drug, with $2.3 billion in 2007 U.S. sales, bears a warning for high risk of clots in arteries.
August 28, 2008 |
What does a company do when there's anecdotal evidence that two of its drugs are equally effective in treating a leading cause of blindness in the elderly, one costing patients $60 per treatment and the other $2,000? In the case of Genentech Inc., nothing. The South San Francisco company declined to seek federal approval for the cheaper drug, Avastin, to treat the wet form of age-related macular degeneration, or AMD. Nor would it help finance -- or cooperate with -- a National Eye Institute study comparing the effectiveness and safety of Avastin, a cancer drug, and the more expensive eye drug, Lucentis.