FDA approves Akeega for BRCA-positive metastatic castration-resistant prostate cancer

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FDA approved Akeega (niraparib and abiraterone acetate), a dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive mCRPC, as detected by an FDA-approved test.

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Pfizer Inc. announced positive results from the phase III TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase inhibitor, in combination with Xtandi (enzalutamide), an androgen receptor pathway inhibitor, demonstrating a statistically significant and clinically meaningful improvement in overall survival compared to placebo plus Xtandi in patients with metastatic castration-resistant prostate cancer, with or without homologous recombination repair gene mutations.

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