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Janssen Nets FDA OK for Akeega With Foundation Medicine CDx in BRCA1/2-Mutated Prostate Cancer

NEW YORK – The US Food and Drug Administration on Friday approved Janssen's Akeega (niraparib and abiraterone acetate) with prednisone for treating BRCA1/2-mutated metastatic castration-resistant prostate cancer, making it the first dual-action tablet containing a PARP inhibitor and hormone therapy.

Patients must have deleterious or suspected deleterious BRCA1/2 mutations as detected by an FDA-approved test in order to be eligible for Akeega, Janssen said in a statement. Between 10 percent and 15 percent of mCRPC patients have BRCA1/2 mutations, and these patients tend to have more aggressive disease and poorer outcomes than those without such mutations.

In concert with approving Akeega, the FDA also approved Foundation Medicine's FoundationOne CDx for identifying mCRPC patients with BRCA1/2 mutations in tumor tissue who may be eligible for Akeega. 

The FDA approved the treatment after reviewing data from the Phase III MAGNITUDE trial, which involved more than 200 mCRPC patients with homologous recombination repair gene mutations, including BRCA1/2 mutations. Akeega-prednisone benefited mCRPC patients with homologous recombination repair gene mutations more than the abiraterone acetate-prednisone combination, but patients with BRCA1/2 mutations fared best on Janssen's treatment.

Patients with BRCA1/2 mutations experienced a 47 percent risk reduction in terms of radiographic progression-free survival on Akeega-prednisone, while in the broader population of patients with homologous recombination repair mutations there was a 24 percent risk reduction. At a second interim analysis, with median follow-up of 24.8 months, median radiographic progression-free survival was 19.5 months among patients with BRCA1/2 mutations on Akeega-prednisone and 10.9 months in the comparator arm.

Among patients with BRCA1/2 mutations, 41 percent on Akeega had a serious adverse event and 15 percent discontinued treatment after having an adverse event because of either the PARP inhibitor or abiraterone acetate component of the therapy.

"The approval of Akeega brings an important treatment option to patients with prostate cancer as they consider their road ahead, and it also highlights the importance of genetic testing and precision medicine for this disease," Shelby Moneer, VP of patient programs and education at the patient advocacy organization ZERO Prostate Cancer, said in a statement. "All individuals diagnosed with prostate cancer should consider genetic testing, especially those from racial and ethnic minority groups who tend to have worse cancer outcomes. This is imperative to close the racial and ethnic disparities in prostate cancer health outcomes."

Janssen's competitors, Pfizer and AstraZeneca, had initially sought approval for their PARP inhibitor-hormone therapy combinations for mCRPC patients regardless of biomarker status. However, in May, the FDA approved AstraZeneca's PARP inhibitor Lynparza (olaparib) with Janssen's Zytiga (abiraterone acetate) and a steroid for mCRPC patients with BRCA1/2 mutations, and in June, the agency approved Pfizer's PARP inhibitor Talzenna (talazoparib) plus Xtandi (enzalutamide) as a treatment for mCRPC patients with homologous recombination repair gene mutations.