Genentech, Biogen Idec receive complete response for cancer drug application

SOUTH SAN FRANCISCO, Calif. The Food and Drug Administration has turned down a request by two biotech companies seeking approval for a drug as a treatment for chronic lymphocytic leukemia.

Biogen Idec and Genentech, now part of Switzerland-based Roche Group, announced that the FDA had given them a complete response letter – a notification that the agency is not ready to grant approval – for their application for Rituxan (rituximab) combined with the chemotherapy drug fludarabine, originally made by Genzyme and now available as a generic, and Baxter’s Cytoxan (cyclophosphamide) as a treatment for people with CLL.

The two companies said they were “committed” to winning approval for the three-drug combination as a CLL treatment, though the FDA did not request any new data in its letter.