FDA Revokes Approval for Avastin as Breast Cancer Treatment

[gdpawel]

According to Tia Ghose at TheScientist, after the FDA revoked its approval of Avastin for the treatment of metastatic breast cancer, the drug maker says it will initiate new trials.

In the wake of the US Food and Drug Administration’s decision to revoke approval of Avastin for the treatment of metastatic breast cancer, drug maker Genentech says it will conduct a new clinical trial to determine which patients are likely to benefit from the drug.

The decision came after an advisory panel unanimously voted to revoke approval in June. The panel found that the drug only slightly decreased tumor size and didn’t increase lifespan compared to patients on standard chemotherapy.

But many patients and doctors suspect the drug is helping at least some women. ”There absolutely may be subsets of carefully chosen breast cancer patients who benefit from Avastin,” Elisa Port, co-director of the Dubin Breast Center at Mt. Sinai Hospital in New York, told Reuters. But currently there is no way to identify those patients.

After the announcement, Genentech said it would an initiate a new Phase III trial to determine if there are certain chemical or genetic markers that could help doctors determine which, if any, patients might get a survival boost from Avastin.

The decision could cost Genentech and its parent company Roche up to $1 billion in sales a year, The New York Times reported. While doctors can still prescribe the drug off-label for use in metastatic breast cancer, the FDA decision could lead insurance companies to drop coverage for the drug, which costs nearly $100,000 a year, ABC News reported.