FDA Grants Breakthrough Therapy Designation to Rucaparib in Metastatic Prostate Cancer
Posted: Tuesday, October 9, 2018
The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy designation to rucaparib (Rubraca) monotherapy for the treatment of adult patients with BRCA1/2-mutated metastatic castration-resistant prostate cancer who have received at least one prior androgen receptor–directed therapy and taxane-based chemotherapy.
Breakthrough Therapy designation was granted based on initial efficacy and safety results from the phase II TRITON2 study (ClinicalTrials.gov identifier NCT02952534) of rucaparib in men with advanced prostate cancer with BRCA1/2 mutations (germline or somatic) and deleterious mutations of other homologous recombination repair genes in the metastatic castration-resistant setting. Initial data from TRITON2 will be presented for the first time at the European Society for Medical Oncology 2018 Congress and then in an oral presentation at the 25th Annual Prostate Cancer Foundation Scientific Retreat.
