FDA hands ap­proval to Janssen's BR­CA-pos­i­tive prostate can­cer com­bo tablet

John­son & John­son’s Janssen scored an FDA ap­proval with its li­censed PARP in­hibitor ni­ra­parib in com­bi­na­tion with abi­raterone ac­etate for the treat­ment of BR­CA-pos­i­tive metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer (mCR­PC), the com­pa­ny an­nounced Fri­day.

The com­bi­na­tion, which was sub­mit­ted for an NDA back in March and re­ceived pri­or­i­ty re­view in April, will be known as Akee­ga and giv­en with pred­nisone. Akee­ga is the “first-and-on­ly” dual ac­tion tablet with both a PARP in­hibitor and abi­raterone ac­etate, Janssen said.

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