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J&J Wins EU Nod For Akeega To Go Up Against AZ/MSD’s Lynparza In First-Line mCRPC

With BRCA-Mutated Niche

Executive Summary

Akeega, a combination of GSK’s PAPR inhibitor Zejula and J&J’s antiandrogenic drug Zytiga, has won a positive opinion from the CHMP in a lucrative first-line prostate cancer setting, hot on the heels of a broader approval for AstraZeneca’s blockbuster Lynparza.

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Akeega Approval Means Three-Way PARP/Anti-Androgen Race In Prostate Cancer Is On

Despite the advantage of a single pill, the J&J drug could have the potential disadvantage of a narrower label in both the US and EU and Lynparza/Zytiga’s potentially higher efficacy.

Pfizer Scores Broad Label For Talzenna/Xtandi In Valuable First-Line Prostate Cancer Indication

The FDA approved the combination for patients with HRR gene-mutated disease, giving it a broader label than the BRCA-mutation label that AstraZeneca/Merck got for Lynparza/Zytiga.

AstraZeneca’s Lynparza Adds Narrow Prostate Cancer Indication

AstraZeneca had hoped data from Phase III PROpel would lead to an all-comers indication in first-line, metastatic castration-resistant prostate cancer, but new indication is limited to BRCA mutations.

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