J&J’s Akeega Advances PARP Inhibition in Prostate Cancer, but FDA Pathway in Broader Patient Subsets Remains Unclear

Akeega, a combination of niraparib (a PARP inhibitor) and abiraterone acetate, is already FDA-approved for men with BRCA-positive metastatic castration-resistant prostate cancer (mCRPC)534.

At ASCO 2025, J&J presented results from the Phase III AMPLITUDE trial in metastatic castration-sensitive prostate cancer (mCSPC) with homologous recombination repair (HRR) gene alterations, showing efficacy and safety for the combination2.

Akeega represents the first PARP therapy for the mCSPC indication, expanding the potential use of PARP inhibitors beyond traditional settings for prostate cancer2.

The clinical benefit was most pronounced in patients with BRCA mutations, suggesting the therapy's strongest impact is in this genetic subgroup4.

While data support earlier use of Akeega in prostate cancer, regulatory clarity from the FDA on its use in broader HRR-mutated (not just BRCA-mutated) populations is still lacking32.

Akeega is a dual-action, once-daily oral tablet, targeting both PARP-mediated DNA repair and androgen biosynthesis, addressing two key oncogenic drivers in genetically defined prostate cancer5.

Sources:

2. https://www.clinicaltrialsarena.com/analyst-comment/asco-2025-akeega-parp-therapy-mcspc/

3. https://www.biopharmadive.com/news/johnson-johnson-akeega-prostate-cancer-hrr-brca-asco/749561/

4. https://firstwordpharma.com/story/5968282

5. https://www.jnj.com/media-center/press-releases/u-s-fda-approves-akeega-niraparib-and-abiraterone-acetate-the-first-and-only-dual-action-tablet-for-the-treatment-of-patients-with-brca-positive-metastatic-castration-resistant-prostate-cancer