Wedoany.com Report-Dec.17, Johnson & Johnson has obtained U.S. regulatory approval to extend the indication for its oncology therapy Akeega to include patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC).

Johnson & Johnson's Akeega has gained approval from the FDA in BRCA2-mutated mCRPC, marking the second prostate cancer indication in which the therapy has been approved.

Akeega combines niraparib, a PARP inhibitor, with abiraterone acetate, an androgen pathway inhibitor, in a single tablet formulation. The approval encompasses use with prednisone, based on findings from the Phase III AMPLITUDE study (NCT04497844). Results showed that Akeega plus prednisone and androgen deprivation therapy reduced the risk of disease progression or death by 54% versus standard treatment approaches.

Johnson & Johnson acquired rights to develop and market niraparib in prostate cancer indications from Tesaro, the original developer, prior to Tesaro's integration into GSK in 2018.

Current standard care for mCSPC typically involves an androgen receptor pathway inhibitor, such as abiraterone, combined with prednisone and androgen deprivation therapy.

This authorization positions Akeega plus prednisone as the first approved dual-action oral precision therapy specifically for BRCA2-mutated mCSPC in the United States.

The regimen's demonstrated efficacy against established care suggests potential to influence future treatment guidelines when combined with androgen deprivation therapy and prednisone.

Johnson & Johnson maintains a longstanding presence in mCSPC management, having initially introduced and commercialized abiraterone (Zytiga), which achieved peak annual sales of $2.5 billion before exclusivity ended in 2018.

Akeega received its initial U.S. approval in 2023 for BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). The new indication broadens its application in earlier disease stages.

The prostate cancer landscape features multiple PARP inhibitor options, including rucaparib from Pharmaand, olaparib from MSD and AstraZeneca, and talazoparib from Pfizer (combined with enzalutamide from Pfizer and Astellas) for mCRPC settings.

Enzalutamide ranked as the leading mCRPC therapy in 2024, generating $5.9 billion in sales for its developers, according to GlobalData's Pharma Intelligence Center.

Projections from GlobalData indicate Akeega could attain peak annual sales of $676 million in 2030, with revenues moderating to $205 million the subsequent year.

This label expansion enhances targeted treatment availability for patients with specific genetic profiles, offering a convenient fixed-dose combination that addresses dual pathways in cancer progression.

By building on abiraterone's established role while incorporating PARP inhibition, Akeega provides an integrated approach suitable for sensitive disease phases.

Clinical evidence supporting risk reduction underscores the value of biomarker-driven selection in optimizing outcomes.

Johnson & Johnson's continued innovation in this area leverages historical expertise alongside acquired assets to address evolving therapeutic needs.

The approval reflects progress in precision oncology, where genetic markers guide regimen choices to maximize benefit.

As competition intensifies with various inhibitor combinations, differentiated profiles aid physician decision-making.

Patient forecasts highlight sustained commercial potential amid a maturing market segment.

Overall, the development reinforces options for managing advanced prostate cancer through scientifically grounded, accessible therapies.