En, als we het toch over Novartis hebben en de collab met Genmab, hierbij weer positief nieuws vers van de pers, met priority review door de FDA voor ofatumumab toepassing. Novartis (Oncology) en Genmab, nu al een mooie match.
US FDA grants Priority Review to sBLA for ofatumumab in combination with fludarabine and cyclophosphamide in relapsed CLL PDUFA target action date of September 10, 2016
COPENHAGEN, Denmark, May 17, 2016 (GLOBE NEWSWIRE) -- Genmab A/S (GEN.CO) announced today that the U.S. Food and Drug Administration (FDA) granted Priority Review to the supplemental Biologics License Application (sBLA) for the use of ofatumumab (Arzerra(r)) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). The application was submitted to the FDA by Novartis in March 2016 under the ofatumumab collaboration between Novartis and Genmab.
Priority Review is an FDA designation for drugs that treat serious conditions and which may provide a significant improvement in safety or efficacy compared to existing standard therapies. The FDA aims to complete its review of the ofatumumab sBLA within six months and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 10, 2016
"With the FDA's acceptance of this sBLA, ofatumumab is one step closer to potentially benefiting an even wider population of patients than it is currently," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We look forward to the FDA's feedback on this application."