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BRIEF-Genmab says U.S. FDA grants priority review for daratumumab in relapsed multiple myeloma
October 7, 2016 / 11:17 PM / a year ago

BRIEF-Genmab says U.S. FDA grants priority review for daratumumab in relapsed multiple myeloma

Oct 7 (Reuters) - Genmab

* u.s. Fda grants priority review for daratumumab in relapsed multiple myeloma

* Sbla was submitted by genmab’s licensing partner, janssen biotech, inc. In august 2016

* Pdufa date set at june 17, 2017

* Fda has assigned pdufa target date of february 17, 2017 to take a decision on daratumumab

* Fda has assigned a prescription drug user fee act (pdufa) target date of february 17, 2017

* Sbla submission also included data from phase i study of daratumumab in combination with pomalidomide and dexamethasone

* Pdufa date for combination of daratumumab with pomalidomide/dexamethasone is june 17, 2017 Source text for Eikon: Further company coverage:

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