As­traZeneca, Mer­ck push block­buster fran­chise to an­oth­er key FDA ap­proval, rel­e­gat­ing a ri­val to sec­ond-fid­dle sta­tus

Prostate can­cer pa­tients have an­oth­er PARP in­hibitor op­tion in a mat­ter of days.

Clo­vis’ Rubra­ca won its prostate can­cer ap­proval on Fri­day, but da­ta from As­traZeneca and Mer­ck ri­val Lyn­parza put a damper on com­mer­cial ex­pec­ta­tions. Now, the FDA has ap­proved Lyn­parza in the prostate can­cer set­ting, months ahead of its ex­pect­ed de­ci­sion date.

Lyn­parza has been ap­proved for pa­tients with metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer (mCR­PC), who car­ry BR­CA or ATM mu­ta­tions, which ac­count for rough­ly 20-30% of pa­tients with mCR­PC. The ap­proval was based on the late-stage PRO­found tri­al, which found the drug eclipsed the im­pact of the an­dro­gen ther­a­pies at re­duc­ing the risk of dis­ease pro­gres­sion or death by a sharp 66%.

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