The Food and Drug Administration’s decision to revoke approval of Roche’s Avastin for advanced breast cancer is likely to curtail use of the $6 billion-a-year drug for such patients. But it’s not likely to put an end to prescribing. Today’s action doesn’t affect the drug’s other approved uses, which include certain types of colon, lung, kidney and brain cancers, the FDA said. And physicians are free to prescribe an approved drug for any use they see fit. One question, though, is whether insurers will cover it. About $1 billion of Avastin’s sales are currently attributed to breast cancer. Many insurers have continued to cover it as the drug’s use in breast cancer came under fire in recent months. The final decision comes nearly four years after the agency OKed the medicine for advanced breast cancer under its accelerated approval program, which enabled patients to get access to the drug before results of large-scale studies were completed. Disappointing findings from those trials triggered a review that finally led to today’s action, in which the agency said the medicine’s risks outweigh the benefits for

patients with the disease. Roche’s Genentech unit issued a statement saying it is “disappointed” in the decision and that it will work to help patients with problems retaining coverage. The company also said that despite the decision, it will move ahead with plans to launch a new phase III study of the drug in combination with the chemotherapy drug paclitaxel in patients with previously untreated advanced breast cancer. In addition, it said is plans to evaluate a potential biomarker that may enable doctors to identify patients more likely to benefit from the drug. Efforts to find such a biomarker for Avastin so far haven’t been fruitful. Elizabeth Thompson, president of Susan G. Komen for the Cure, said in a statement that the patient advocacy group respects the time the agency took to consider the decision. She also said the organization wants to make sure women currently using the medication continue to have access to it and that insurers continue to cover it for such patients.

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What Does the FDA’s Avastin Decision Mean for Breast Cancer Patients?