FDA gives GSK, Genmab's Arzerra 'breakthrough' designation

Arzerra, the leukemia drug from GlaxoSmithKline ($GSK) and Genmab, is not a big seller, bringing in less than $100 million last year, but it has been given a chance to do much better. The company said Friday that the FDA had granted it a "breakthrough therapy" designation for first-line use in certain cases.

The FDA will fast-track review of the drug for use in combination with chlorambucil for the patients with chronic lymphocytic leukemia (CLL) who have not received any previous treatment and are inappropriate for fludarabine-based therapy. The designation allows for a quickened approval process for drugs with potential for serious and life-threatening diseases. CLL is the most common form of leukemia in adults, and GSK said it is estimated there will be more than 15,680 new cases and more than 4,580 deaths in the U.S. this year. 

"We are actively working on our submission and look forward to the enhanced regulatory interaction allowed for Breakthrough Therapies," said Dr. Kathy Rouan, vice president and head of biopharmaceutical development at GSK.

The FDA approved Arzerra (ofatumumab) for chronic lymphocytic leukemia in 2009 after an accelerated approval process for the antibody therapy at that time. But the second-line use has kept it from getting much traction. Glaxo licensed the drug three years ago in a $2.1 billion deal. Arzerra is designed to attach to the CD20 molecule found on B cells, which are vulnerable to leukemia. 

- here's the announcment