FDA Accelerates Review of Darzalex Combinations in Multiple Myeloma

FDA granted priority review to a supplemental BLA for Darzalex (daratumumab) for pre-treated multiple myeloma.

Darzalex, a monoclonal antibody developed by Genmab, is being evaluated in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone. The sBLA was submitted by Genmab’s licensing partner, Janssen Biotech. The FDA has assigned an expedited PDUFA target date of Feb. 17, 2017, to make a decision on Darzalex, which previously received a Breakthrough Therapy designation.

In addition, the agency granted a standard review period for the use of Darzalex in combination with pomalidomide and dexamethasone for the treatment of patients with relapsed or refractory multiple myelomas who have received at least two prior therapies, with a proteasome inhibitor and an immunomodulatory agent, with a target date of June 17, 2017.