FDA, EMA move against Avastin for breast cancer

The fight over breast-cancer treatment with Roche's Avastin has come to a head: U.S. officials decided to revoke the drug's indication for breast cancer, and European Medicines Agency moved to restrict it for use with only one type of chemotherapy. The decisions stand to cut more than $1 billion off Avastin's $6 billion in annual revenues, and they're sure to draw fire from folks who've been advocating for the drug.

FDA and EMA have been reviewing Avastin's utility in breast cancer since new trial data showed little benefit for patients with the disease; it stalled cancer growth for up to three months and didn't prolong patients' lives, the news service notes. An FDA advisory panel voted to withdraw the drug's indication for breast cancer, and even some patient advocates believed that the drug's breast cancer approval should be revoked. Meanwhile, the U.K.'s cost-effectiveness watchdog not only rejected Avastin in breast cancer, it gave the drug a poor review in other cancers earlier this week.

Others, including some vocal U.S. lawmakers, accuse the FDA of prejudice against the drug because of its high cost--and cost isn't supposed to be a factor in FDA approval decisions. The company maintains that Avastin is an important option for cancer patients. 

Of course, revoking Avastin's breast cancer approval doesn't mean that doctors can't prescribe it for that use. It does mean, however, that insurers may stop covering the drug for breast cancer patients. Patient groups are lobbying insurance companies to keep paying for the drug for patients who are already using it, despite the FDA's negative decision.

- see the Reuters story

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