FDA greenlights Johnson & Johnson’s Akeega for BRCA-positive prostate cancer

USA — Johnson & Johnson has secured the coveted FDA approval for Akeega, a pioneering combination tablet poised to redefine the landscape of metastatic castration-resistant prostate cancer (mCRPC) treatment in adults with BRCA-positive mutations.

This regulatory milestone follows a series of triumphs, including nods from the EU earlier this year and clearance in Canada, accentuating the profound impact of this therapeutic breakthrough.

The resounding FDA approval catapults Akeega, an ingenious fusion of J&J’s PARP inhibitor niraparib and the dynamic ingredient from its blockbuster androgen inhibitor Zytiga (abiraterone acetate), into the forefront of first-line mCRPC treatment.

This accolade is especially significant for patients harboring BRCA1 or BRCA2 mutations, illuminating a path toward enhanced therapeutic outcomes and a potential extension of survival.

While the EU and Canada have previously embraced Akeega’s promise, the competitive arena paints a nuanced picture.

Akeega finds itself in direct competition with AstraZeneca and MSD’s Lynparza (olaparib) in Europe, where Lynparza enjoys the privilege of being utilized alongside Zytiga without mutation-based restrictions.

Johnson & Johnson acquired global rights to niraparib outside Japan for uses in prostate cancer via a 2016 deal with Tesaro, which was later acquired by GSK.

The UK company holds rights to the drug in other indications, and it is already marketed in Europe and elsewhere as a treatment for ovarian cancer under the name Zejula.

Notably, the US evens the playing field, confining the Lynparza/Zytiga combination exclusively to BRCA-mutated patients.

Patient organization ZERO Prostate Cancer underscores the pivotal role of Akeega, heralding it as a vital option for individuals grappling with this form of cancer.

This approval underscores the indispensable importance of genetic testing and precision medicine in navigating the complexities of prostate cancer.

The FDA’s approval stems from the remarkable phase 3 MAGNITUDE trial, where Akeega proved its mettle.

A resounding testament to its potential, the trial showcased that augmenting Zytiga with niraparib led to a 47% enhancement in radiographic progression-free survival (rPFS) among untreated mCRPC patients harboring BRCA1/2 mutations, compared to the standard of care.

While Akeega’s impact is undeniable, nuances emerge when dissecting the trial results. The combination, while transformative for BRCA-mutated patients, exhibited limitations in improving rPFS in mCRPC patients without homologous recombination repair (HRR) mutations.

BRCA accounts for a significant portion of HRR cases, yet Akeega’s efficacy was most pronounced within the BRCA mutation subgroup, signaling potential avenues for targeted interventions.

A dynamic market landscape

Pfizer’s Talzenna (talazoparib) enters the fray as a potent contender, securing FDA approval in June for mCRPC patients with HRR mutations.

Talzenna, in tandem with anti-androgen therapy Xtandi, showcased a remarkable 37% reduction in rPFS among a diverse population, escalating to an astounding 55% reduction for patients bearing HRR mutations.

Prostate cancer, the second-most prevalent cancer diagnosis among men, remains a formidable challenge, marked by stubbornly low five-year survival rates hovering around 15%.

Against this backdrop, Akeega’s FDA endorsement stands as a beacon of hope, reshaping the therapeutic landscape and inspiring optimism for improved survival prospects.

The FDA’s dual approval accolade for Akeega and Talvey (talquetamab), a groundbreaking CD3xGPRC5D bispecific antibody for multiple myeloma, heralds a triumphant chapter for Johnson & Johnson’s oncology endeavors.

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