On Friday, the FDA gave the nod to Janssen Pharmaceutical’s combination of niraparib and abiraterone acetate, branded as Akeega, designed to treat metastatic castration-resistant prostate cancer in patients with the BRCA mutation.
Janssen, a branch of Johnson & Johnson, revealed that Akeega is the inaugural dual-function tablet fusing the capabilities of a PARP inhibitor and abiraterone acetate, an androgen blocking agent previously marketed by Janssen as Zytiga.
The authorization encompasses using Akeega alongside prednisone, relying on insights from the Phase III MAGNITUDE study. This double-blind, placebo-controlled trial with 765 participants demonstrated that the Akeega-based approach enhanced radiographic progression-free survival by 47% in BRCA-mutated patients, when juxtaposed with a Zytiga and prednisone combination.
Furthermore, Akeega indicated a potential uplift in overall survival, even though the results weren’t statistically definitive. The combination using Akeega also marked progress in secondary measures like the delay to symptomatic progression and postponement of starting cytotoxic chemotherapy.
From a safety standpoint, side effects observed with the Akeega regimen were in line with the expected effects of its individual components. Predominant adverse reactions included musculoskeletal discomfort, fatigue, constipation, and raised blood pressure. A 15% segment of the study participants opted out of using Akeega due to these side effects.
The clearance of Akeega “introduces a pivotal treatment alternative for prostate cancer sufferers,” articulated Shelby Moneer, the VP of patient programs and education at the non-profit organization ZERO Prostate Cancer. It’s notable that Moneer hadn’t received any compensation for media engagements, as highlighted by Janssen.
In the prostate cancer landscape, Akeega will be competing against AstraZeneca’s and Merck’s Lynparza, which gained FDA’s approval in May 2020 for mCRPC patients with HRR gene abnormalities. By June 2023, the approval extended to BRCA mutation carriers in combination with abiraterone and prednisone.
Pfizer’s Talzenna, another PARP inhibitor, also earned its place in the prostate cancer treatment arena in June, specifically for HRR-mutated mCRPC, and is to be used in tandem with Xtandi, co-developed with Astellas.
Rounding off the week, Janssen celebrated another FDA endorsement on Thursday when its bispecific antibody, Talvey, was fast-tracked for treating recurrent or persistent multiple myeloma. This product bears a highlighted warning for potential cytokine release syndrome and neurological adverse effects.