BioCentury
ARTICLE | Regulation

Accelerate, or not

June 1, 2009 7:00 AM UTC

Arzerra ofatumumab from Genmab A/S and partner GlaxoSmithKline plc would appear to be a classic example of why accelerated approval was created. With last Friday's 10-3 vote by the Oncologic Drugs Advisory Committee to recommend approval of Arzerra to treat chronic lymphocytic leukemia, the question now is whether FDA will follow ODAC's advice or be swayed by the lack of consistency on reported results for the surrogate endpoint of objective response rate.

Granting accelerated approval would provide the anti-CD20 mAb to a highly refractory population of CLL patients who have failed multiple drugs, and allow the companies to generate revenues in the five years it will take to complete two ongoing Phase III trials...