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(RTTNews) - Johnson & Johnson (JNJ) today announced that the European Commission (EC) has approved AKEEGA, a dual-action tablet, for the treatment of adult patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer (mHSPC).

Prostate cancer is the second most common cancer in men worldwide, and BRCA mutations are linked to more aggressive disease and poorer outcomes.

AKEEGA combines two mechanisms in one pill: Niraparib, a PARP inhibitor that blocks DNA repair in cancer cells, and abitaterone acetate, which reduces testosterone production to slow tumor growth. Taken with Prednisone, the therapy aims to delay disease progression and improve survival in this high-risk patient group.

The European approval was supported by data from the Phase 3 AMPLITUDE trial, which demonstrated significant benefit in BRCA-mutated patients, with findings, presented at ASCO 2025. The earlier MAGNITUDE trial had supported FDA approval in 2023 for BRCA-mutated mCRPC.

AKEEGA is already available in other parts of the world. The U.S. FDA approved the drug in August 2023 for patients with BRCA-mutated metastatic castration-sensitive prostate cancer (mCSPC) and metastatic castration-resistant prostate cancer (mCRPC). In Europe AKEEGA has previously been cleared for mCRPC, and this new decision expands its use to earlier-stage metastatic disease (mHSPC).

According to GlobalData's Pharma Intelligence Centre, Johnson & Johnson's AKEEGA is projected to generate $178 million in revenue by 2031.

JNJ has traded between $141.50 and $251.71 over the past year. The stock closed Friday's (March 6, 2026) trading at $240.40, up 0.32%. In pre-market the stock is at $237.45, down 1.25%.

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