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

 
• By Alaric DeArment

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.

J&J's Akeega won FDA approval on 11 August • Source: Shutterstock

The anticipated three-way competition between PARP inhibitor and anti-androgen drug combinations in adults with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer (mCRPC) is now official with the US Food and Drug Administration approval of Akeega (niraparib and abiraterone acetate), from Johnson & Johnson’s Janssen Pharmaceutical Cos.

Still, while the single pill could make for a convenience advantage, Akeega has two potential disadvantages in the form of its label and its efficacy profile relative to its main competitors: AstraZeneca PLC/Merck & Co., Inc.’s combination of Lynparza (olaparib) and Zytiga (abiraterone acetate) and Pfizer Inc.’s combination of Talzenna (talazoparib) and Xtandi (enzalutamide). Akeega’s label is narrower than Lynparza/Zytiga’s in Europe and Talzenna/Xtandi’s in the US, while the pivotal Phase III MAGNITUDE trial of Akeega showed lower efficacy than the PROpel trial of Lynparza/Zytiga

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