Avastin 治疗乳癌没戏?

hy2007

December 5, 2007, 4:01 pm
Thumbs-Down for Avastin for Breast Cancer
Posted by Shirley S. Wang

A panel of advisors to the FDA voted 5-4 today against Genentech’s bid to market its cancer drug Avastin for advanced breast cancer patients because the risks outweigh benefits, reports Dow Jones Newswires. FDA will make the final call, but the vote against Genentech doesn’t bode well.

As the Health Blog noted earlier this week, Avastin, which is currently marketed in the U.S. to treat non-small-cell lung and colon cancer, appears to slow the progression of breast cancer by a median of 5.5 months. But it doesn’t improve breast cancer patients’ overall survival rate.

The data also suggest that Avastin is potentially more toxic than chemotherapy. About 2% of women in the study on chemo plus Avastin died, whereas no one who got chemotherapy alone did. Bloomberg notes that FDA’s briefing documents said patients on the drug had a 20% increase in serious side effects, including death.

The FDA hasn’t approved a breast-cancer treatment on slowed progression of the disease, called progression-free survival, as a first-line treatment for advanced breast cancer. “I think there are other agents out there that are available for this patient population,” said Maha Hussain, chairwoman of FDA’s oncology drugs advisory panel who voted against Avastin.

Genentech is seeking approval of Avastin as a combination treatment with the chemotherapy drug paclitaxel in women with advanced breast cancer who haven’t had chemo before. The company has argued there’s a benefit to slowing down cancer progression and that data uggest Avastin did improve survival, though the change wasn’t statistically significant.

Avastin rang up $1.69 billion in the first three-quarters of 2007. Annual sales could rise by $1.3 billion if Avastin were approved for breast cancer, according to analyst estimates cited by Bloomberg. The company’s stock dropped $6.58, or 9%, to $66.20. Trading was halted shortly after the vote.