FDA panel says No to Genentech's Avastin

U.S. biotechnology company Genentech Inc. suffered a major setback Wednesday, when the U.S. Food and Drug Administration (FDA) advisory panel refused to approve its high-profile drug Avastin as a treatment for breast cancer.

The expert panel’s decision came after the Food and Drug Administration on Monday (Dec. 3) released a review of the drug in which the agency stated that Genentech’s blockbuster cancer drug Avastin doesn't seem to significantly lengthen the lives of women with breast cancer, and may increase the risk of death.

The fresh analysis by the federal agency’s staff showed that the breast cancer treatment drug Avastin failed to help patients with advanced breast cancer live longer, and had serious side effects, including cardiovascular problems, bowel perforations, and deaths.

The US health watchdog FDA at the time has said that it would ask outside experts for a recommendation on whether Avastin should be approved to treat breast cancer. An expert advisory panel was due to hold a meet on Wednesday in Gaithersburg, Maryland to discuss whether Avastin will win approval for breast cancer.

In the meeting yesterday, members of the advisory committee voted 5-4 and decided that Avastin’s ability to delay the worsening of cancer did not outweigh the drug’s toxic side effects.

“Absolutely it’s a very painful reality that metastatic breast cancer is not curable,” said Natalie Compagni Portis, a patient representative on the committee, who voted against Avastin’s approval. However, she added, “I don’t think that means that we should just say, ‘Well, here, try this,’ if there isn’t meaningful data to support it.”

The panel made its decision after reviewing findings from a study showing Avastin, also called bevacizumab, failed to show a major benefit in breast cancer patients who had already taken two chemotherapy drugs.

In a clinical trial, sponsored by the National Cancer Institute, the experts have noted that Avastin slowed the spread of tumors compared with patients given only chemotherapy drug paclitaxal, a generic drug also sold as the branded treatment Taxol.

They found that adding Avastin to the drug paclitaxel though nearly doubled the time before tumors worsened, but the Avastin-chemotherapy combination did not appear to significantly improve the overall survival of patients. In addition, Avastin along with chemotherapy caused some disturbing side effects, including hypertension, congestive heart failure and perforated bowels.

Now, the ultimate decision will be made by the FDA. Although FDA is not bound to follow its advisory panel's recommendations, it generally follows their guidance. The agency makes a decision on whether a product should be approved after evaluating all data and considering the recommendations of the advisory committee.

Wednesday's 5-4 vote on Avastin was a rare setback for Genentech, which was seeking drug’s approval for advanced breast cancer in patients who haven't previously received treatment.

"We appreciate the consideration that FDA panel made but are disappointed with their decision," said Genentech spokesman Edward Lang. "We hope to work with the agency in the coming weeks."

Avastin is the South San Francisco drug company’s second biggest money maker, and is already a blockbuster drug for colon and lung cancer. It was first approved on 26th Feb, 2004 as a first line treatment for metastatic colorectal cancer, in combination with intravenous 5-FU based chemotherapy. The drug was also approved on 11th Oct, 2006 as the first line treatment of patients with locally advanced, recurrent or metatatic non-squamous, non-small cell, lung cancer.