European regulators have given a positive recommendation to expand the use of Akeega, a combination of niraparib and abiraterone, for patients with metastatic hormone-sensitive prostate cancer who carry BRCA1 or BRCA2 mutations. If approved, this pill—taken with prednisone and standard hormone therapy—would offer a targeted treatment option earlier in the disease, based on a patient’s genetics.
The decision is based on results from the Phase 3 AMPLITUDE trial. In patients with BRCA1/2 mutations, the combination significantly delayed cancer progression compared with standard treatment alone. Nearly half the risk of disease progression or death was reduced, and symptomatic worsening was also much less common. Early results also suggest a possible overall survival benefit, though longer follow-up is still needed.
The treatment did cause more side effects than standard therapy. Severe side effects were more frequent, including anemia, high blood pressure, and low potassium levels, and about 15% of patients stopped treatment because of toxicity. Even so, experts say the benefits are important because BRCA-mutated prostate cancer is usually more aggressive, and this approach marks a move toward more personalized, precision-based cancer care.