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ARTICLE | Company News

FDA grants Darzalex Priority Review for first-line MM

January 19, 2018 11:53 PM UTC

Genmab A/S (CSE:GEN; Pink:GMXAY) said FDA accepted and granted Priority Review to an sBLA from partner Johnson & Johnson (NYSE:JNJ) for Darzalex daratumumab to treat multiple myeloma in the first-line setting. The PDUFA date is May 21. Genmab announced the news after market close on Friday.

The sBLA is seeking approval of Darzalex in combination with Velcade bortezomib, melphalan and prednisone (VMP) to treat newly diagnosed MM in patients who are ineligible for an autologous stem cell transplant (ASCT)...

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