FDA grants priority review for Genmabs’ daratumumab to treat relapsed multiple myeloma
Posted: 12 October 2016 | | No comments yet
The FDA has assigned a prescription drug user fee act (PDUFA) target date of February 17, 2017 to take a decision on daratumumab in this indication…
The US Food and Drug Administration (FDA) has granted priority review to the supplemental biologics license application (sBLA) for the use of Genmab’s Daratumumab (darzalex) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
The sBLA was submitted by Genmab’s licensing partner, Janssen Biotech in August 2016. Priority review is an FDA designation for drugs that treat a serious condition and may provide a significant improvement in safety or efficacy.
PDUFA
The FDA has assigned a prescription drug user fee act (PDUFA) target date of February 17, 2017 to take a decision on daratumumab in this indication. In addition, the FDA has granted a standard review period for the use of daratumumab in combination with pomalidomide and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, with a proteasome inhibitor and an immunomodulatory agent.
The PDUFA date for the combination of daratumumab with pomalidomide/dexamethasone is June 17, 2017.
“People suffering from multiple myeloma always ultimately relapse after receiving treatment with the therapies available today. The application for daratumumab in combination with current backbone therapies for patients who have already received at least one type of treatment is a key step towards trying to bring new treatment options to patients with multiple myeloma,” said Genmab’s CEO Jan van de Winkel, PhD.
Two supporting studies
The sBLA submission included data from two Phase III studies: the CASTOR study of daratumumab in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma, and the POLLUX study of daratumumab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with relapsed or refractory multiple myeloma.
The submission also included data from the Phase I study of daratumumab in combination with pomalidomide and dexamethasone in relapsed or refractory multiple myeloma.
