[Beacon Staff]

Daratumumab gets priority review by the U.S. FDA

by Beacon Staff on Fri Sep 04, 2015 3:59 pm

Lots of regulatory news this week. This time, it concerns daratumumab. Johnson & Johnson announced this afternoon that the drug has been granted priority review by the U.S. Food and Drug Administration. A final decision on the drug's application to be approved as a new treatment for multiple myeloma is expected by March 9, 2016.

Here is a link to Johnson & Johnson's press release announcing the FDA decision to grant daratumumab priority review.

And here are a few excerpts:

the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for daratumumab as a treatment for patients with multiple myeloma who are refractory to both a pro­tea­some inhibitor (PI) and an immunomodulatory agent (IMiD), or who have received three or more prior lines of therapy, including a PI and an IMiD ...

The FDA grants Priority Review to investigational therapies that if approved, may offer significant im­prove­ments in the treatment, prevention or diagnosis of a serious condition.1 This designation shortens the review period to six months compared to 10 months for Standard Review. With today's announcement, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of March 9, 2016 to render a decision on the daratumumab application.

Genmab, the Danish biotech company that originally developed daratumumab, also issued a press release today about the FDA priority review of the drug. The content of the Genmab press release is very similar to the content of the J&J press release.