Nicholas Wrigley

The approval of the niraparib/abiraterone dual-action tablet for BRCA-positive mCRPC is based on findings from the phase 3 MAGNITUDE study.

“To our knowledge, these results are the first to suggest an association between second-generation [antiandrogens] and cognitive and functional toxic effects based on data from prospective [randomized controlled trials],” the investigators wrote.

The application is supported by findings from the phase 3 MAGNITUDE study.

The median progression-free survival (PFS) was 16.9 months (95% CI, 11.5-not estimable) with cabozantinib vs 11.3 months (95% CI, 7.7-14.0) with placebo in the PFS intention-to-treat population.

The combination use of niraparib plus abiraterone and prednisone continued to improve outcomes in patients with metastatic, castration-resistant prostate cancer and HRR gene alterations.

Adding trilaciclib to platinum-based chemotherapy and maintenance avelumab yielded responses in patients with untreated, locally advanced or metastatic urothelial carcinoma.