J&J wins snap ap­proval of apa­lu­tamide, the first drug OK'd for non­metasta­t­ic prostate can­cer

The FDA has giv­en J&J a big boost to­day, cut­ting its pri­or­i­ty re­view for apa­lu­tamide down to a quick once over and a snap ap­proval months ahead of its PDU­FA date for non­metasta­t­ic prostate can­cer.

The drug will now be sold as Er­leade, hand­i­ly beat­ing a ri­val sup­ple­men­tal ap­pli­ca­tion from Pfiz­er on its can­cer drug Xtan­di. This ap­proval came through just two months af­ter the agency of­fered to give it a pri­or­i­ty re­view, un­der­scor­ing how fast reg­u­la­tors are will­ing to act.

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