🧪 FDA okays Akeega for BRCA2+ castration-sensitive PCa

The FDA has expanded approval of J&J's Akeega (abiraterone/niraparib) plus prednisone for adults with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC), based on Phase III AMPLITUDE trial data.

Why It Matters To Oncology

▪ Akeega is now approved earlier in the prostate cancer treatment sequence for a genomically defined group with poor prognosis and few tailored options.

▪ AMPLITUDE showed a 54% reduction in risk of progression or death for BRCA2-mutated patients, but minimal benefit in non-BRCA2 subsets.

The Financials

▪ J&J's prostate cancer portfolioalready anchored by Zytiga and Erleadagains further depth.

▪ The move follows J&J's $3.1B acquisition of Halda Therapeutics and its next-gen prostate cancer asset.

What They're Saying

▪ FDA: "The magnitude of benefit appeared to be driven by patients with BRCA2 mutations."

▪ Analysts expect the label expansion to increase Akeega's market penetration in precision oncology.

What's Next

▪ Further survival data from AMPLITUDE, especially for non-BRCA2 populations, are awaited.

▪ J&J to integrate Halda's HLD-0915 into its prostate cancer pipeline, potentially targeting castration-resistant disease.