FDA ad­vi­so­ry com­mit­tee votes against plan for broad use of prostate can­cer drug

An FDA ad­vi­so­ry com­mit­tee on Fri­day vot­ed against As­traZeneca and Mer­ck’s bid to ex­pand its Lyn­parza la­bel to all adult pa­tients with metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer (mCR­PC).

The drug, a PARP in­hibitor al­so known as ola­parib, was ap­proved in 2020 for mCR­PC pa­tients who have a ge­net­ic mu­ta­tion called ho­mol­o­gous re­com­bi­na­tion re­pair (HRR). The lat­est ap­pli­ca­tion sought to al­low Lyn­parza to be used in pa­tients with or with­out HRR mu­ta­tions in com­bi­na­tion with abi­raterone (J&J’s brand­ed Zyti­ga) and pred­nisone or pred­nisolone alone.

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