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Quick FDA approval for Darzalex in second-line MM

November 22, 2016 12:01 AM UTC

Genmab A/S (CSE:GEN) said FDA approved Darzalex daratumumab in combination with dexamethasone and either Revlimid lenalidomide or Velcade bortezomib to treat multiple myeloma in patients who have received at least one prior therapy. The approval came well ahead of Darzalex's Feb. 17, 2017 PDUFA date in the indication, and triggers a $65 million milestone payment to Genmab from partner Johnson & Johnson (NYSE:JNJ).

Darzalex has accelerated approval from FDA to treat MM in patients who have failed at least three prior therapies, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent. It remains under FDA review as a third-line MM therapy in combination with Pomalyst pomalidomide and dexamethasone in patients previously treated with a PI therapy and an immunomodulatory agent. The PDUFA date in that indication is June 17, 2017...

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