[Beacon Staff]

Daratumumab submission to FDA has started

by Beacon Staff on Fri Jun 05, 2015 2:22 pm

Hello everyone,

Some good news. The process of getting daratumumab approved by the FDA as a new multiple myeloma therapy has started.

The company that initially started development of daratumumab, Genmab, announced a short while ago that its partner – Johnson & Johnson – has started a "rolling submission" to the FDA of an application to have daratumumab approved as a new treatment for relapsed multiple myeloma.

Here's the first part of the related press release, which you can read in full here at the Beacon:

Genmab Announces Start Of Rolling Submission Of Biologics License Application For Daratumumab For Double Refractory Multiple Myeloma To The FDA

Copenhagen (Press Release) – Genmab A/S (OMX: GEN) announced today its licensing partner Janssen Biotech, Inc. has initiated a rolling submission of a Biologics License Appli­ca­tion (BLA) to the U.S. Food and Drug Administration (FDA) for daratumumab. The submission is for daratumumab as a treatment for patients with multiple myeloma who have received at least three different lines of therapy including both a pro­tea­some inhibitor and an immuno­modulatory agent (IMiD) or who are double refractory to a pro­tea­some inhibitor and an IMiD. A rolling submission allows completed portions of the application to be submitted to the FDA on an ongoing basis. The FDA grants this type of review if the agency determines after a pre­lim­i­nary evaluation of clinical data that the breakthrough therapy may be effective and there­fore will consider reviewing portions of an application before the submission is complete. In August 2012, Genmab and Janssen Biotech, Inc. entered an agreement which granted Janssen a worldwide exclusive license to develop, manufacture and commercialize daratumumab. Janssen is currently the sponsor of all but one study globally.

The submission includes data from the Phase II study (Sirius MMY2002) of daratumumab in multiple mye­lo­ma patients who have received at least three prior lines of therapy including both a pro­tea­some inhibitor and an IMiD or who are double refractory to a pro­tea­some inhibitor and an IMiD. However, safety and efficacy data from the Phase I/II study (GEN501) and safety data from three other studies, have also been included in the BLA submission. Daratumumab received a Breakthrough Therapy Designation (BTD) for this indica­tion from the FDA in May 2013.

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Positive data about daratumumab efficacy in myeloma were presented at the recent ASCO meeting. The Beacon's article on those results, which includes a link to the full presentation, can be found here:

"Daratumumab Continues To Show Substantial Promise As Potential New Treatment For Multiple Myeloma (ASCO 2015)", The Myeloma Beacon, May 30, 2015.

[Beacon Staff]

Re: Daratumumab submission to FDA has started

by Beacon Staff on Fri Jun 05, 2015 6:30 pm

Here's the Beacon's news article on today's daratumumab news. We currently estimate that, based on the news, an FDA decision on whether to approve daratumumab as a new myeloma therapy could be made by the first quarter of next year.

"Daratumumab FDA Application And Review Process Starts," The Myeloma Beacon, June 5, 2015