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.
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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 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.
J&J has only been able to gain approval in BRCA-positive patients in the EU, while AstraZeneca’s rival combination can treat all metastatic prostate cancer patients.