Wrapping up a rare two-day appeal hearing, the U.S. FDA Panel reiterated its view that Avastin is not clinically beneficial, effective or safe for treating breast cancer—to a fiery response from patients, who earlier shared tearful testimonies that the drug saved their lives.
Roche argued that Avastin, which generated $6 billion in sales to treat several types of cancers, should remain available to breast cancer patients while the company conducts more studies on its clinical benefits.
Without FDA approval, insurance companies and government health programs likely will stop covering the $8,000-a-month drug, potentially jeopardizing treatment for an estimated 17,000 women using the medicine.
FDA officials said the side effects and unclear effectiveness of the drugs presented in the latest data makes approval of Avastin for breast cancer inappropriate, especially since follow-up studies of the drug would take at least three-and-a-half years—and even longer for final results.
The company said the drug works best with a specific type of chemotherapy called paclitaxel, and follow-up studies would look at that combination, as well as which patients best respond to treatment.
The company also has said Avastin may work better for certain kinds of patients based on their genetic markers, and future studies would look at how best to identify them.
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