Panel Rejects Drug For Breast Cancer Use

Advises FDA To Not Approve Genentech's Avastin In Breast Cancer Patients

(AP)  Government advisers on Wednesday said Genentech drug Avastin should not be approved for expanded use in breast-cancer patients.

After weighing evidence on whether the drug meaningfully improves life for patients with advanced breast cancer, Food and Drug Administration advisers voted 5 to 4 against recommending approval. FDA is not required to follow the recommendations of its panel, though it usually does.

South San Francisco-based Genentech Inc. asked the FDA to approve the drug for use alongside chemotherapy in breast cancer patients who have not already taken other drugs.

Prior to the meeting, FDA scientists said that while Avastin slowed the progression of cancer, it did not improve patients' lifespan overall. Scientists questioned whether the drug should be approved for the new use, considering toxicity issues and side effects, which include heart attack, hypertension and blood clots.

Avastin is currently approved for patients with certain types of colon and lung cancer. It was the company's second best-selling product last year with revenue of $1.7 billion.

The negative panel vote Wednesday is the second FDA-related setback for Avastin as a breast cancer therapy. Last September, FDA asked the company to resubmit medical scans showing cancer progression in patients. The agency is scheduled to make its final decision on Avastin in February.

Analysts said the panel's decision will have implications for all drug makers working on cancer therapies. Increasingly, companies will have to show overall survival improvement to gain U.S. approval, rather than just delayed cancer progression.

Shares of Genentech fell 6.6, or 9 percent, to $66.18 before trading in the stock was halted at 2:29 p.m. EST. As of 3:55 p.m., trading had not yet resumed.

[rushman71]

OldThought: You are soooooo right about this!!! And even if they did find a cure, and started selling it over the counter, it would be sold at an outrageous price. But we all know that as these "test" go on, and with a lot of our tax paying money going towards these so called "test", they will--intentionaly--never discover the cure!!!

[Netterz]

" It was the company''s second best-selling product last year with revenue of $1.7 billion. " THIS my friends... is EXACTLY why there is not, and will not be a cure for cancer, ever. Not a long as they are making this kind of money for the drugs,, then the gv''t makes all the $ off the taxes they pay on the revenue, which are actually a plant based form of rat poisen.