The FDA has granted full approval to rucaparib (Rubraca) for adults with BRCA-mutated metastatic castration-resistant prostate cancer.
The decision is based on a confirmatory analysis of a randomized trial of 405 patients who had progressed on prior androgen receptor pathway inhibitors, according to a Dec. 17 news release from the agency. Among the 302 patients with BRCA mutations, rucaparib showed a statistically significant improvement in radiographic progression-free survival compared to standard treatments, with a median of 11.2 months versus 6.4 months.
Rucaparib received accelerated approval in 2020 for a similar indication. The agency said patients should be selected using an FDA-approved companion diagnostic.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.