FDA Accepts Ofatumumab in Combination with Fludarabine and Cyclophosphamide for Priority Review

The US Food and Drug Administration (FDA) has granted Priority Review to ofatumumab (Arzerra) for use in combination with fludarabine and cyclophosphamide to treat patients with relapsed chronic lymphocytic leukemia (CLL). A review period of 6 months is expected. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 10, 2016.¹

The status of Priority Review may be granted to drugs that hold promise of significant improvement over current treatments. A detailed review process evaluates the drug in question, and significant improvement is typically defined as increased effectiveness in treatment or prevention of a condition, elimination or substantial reduction of a treatment-limiting drug reaction, evidence of effectiveness in a new subpopulation, or documented enhancement of patient adherence that is expected to improve outcomes.

The Priority Review application, submitted by Novartis in March 2016, was based on results from a Phase III study, COMPLEMENT 2, that reviewed the effectiveness of ofatumumab used in combination with fludarabine and cyclophosphamide (FC) vs FC alone in patients with relapsed CLL. The COMPLEMENT 2 study included 365 patients with relapsed CLL; patients were randomized to receive either ofatumumab in combination with FC, or FC alone. The primary end point was met, displaying a median progression-free survival in patients receiving ofatumumab in combination with FC of 28.9 months vs 18.8 months for patients who only received FC (HR = 0.67, P = .0032). Data from this trial were published in April 2015.

Chronic lymphocytic leukemia is the most common form of leukemia, accounting for nearly a third of adult leukemias in the United States.

Reference

1. Ofatumumab in combination with fludarabine and cyclophosphamide for relapsed CLL accepted for priority review by FDA [news release]. genmab Web site. http://ir.genmab.com/releasedetail.cfm?ReleaseID=971420. Posted May 17, 2016. Accessed May 31, 2016.