PROSTATE CANCER: The FDA have granted priority review for the PARP inhibitor rucaparib in the mCRPC setting, based on data from the phase II TRITON2 trial which showed ORR 43.9% for BRCA1/2 mutation carriers.
FDA Grants Priority Review to Rucaparib for BRCA1/2-Positice mCRPC
Kristie L. Kahl January 16, 2020 Prostate Cancer, News
The FDA granted priority review to rucaparib (Rubraca) for the treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castration-resistant prostate cancer (mCRPC), according to Clovis Oncology, the drug’s manufacturer.1 The agency set a Prescription Drug User Fee Act (PDUFA) date of May 15, 2020. The application is based on findings from the ongoing, international, multicenter, open-label phase II TRITON2 trial that enrolled male patients with mCRPC associated with 1 of 13 homologous recombination repair (HRR) gene alterations. Patients were treated with rucaparib at 600 mg twice daily until radiographic progression or treatment discontinuation. The primary endpoints of the trial include confirmed ORR per RECIST/Prostate Cancer Clinical Trials Working Group 3 criteria in patients with measurable disease at baseline and PSA response in patients with no measurable disease at baseline. Patients treated with the PARP inhibitor induced a 43.9% confirmed objective response rate (ORR; 95% CI, 24.4%-65.1%) by investigator assessment in 57 RECIST–evaluable patients with BRCA1/2-mutant mCRPC. Among those with BRCA1/2 alterations, 51.1% had a confirmed PSA response to rucaparib. All 11 investigator-assessed radiographic responses in the patients with BRCA-mutated tumors were partial responses (PRs); 9 patients (36.0%) had stable disease. The median duration of response had not been reached. The most common any-grade treatment-emergent adverse events occurring in >20% of patients were asthenia/fatigue (55.3%), nausea (49.5%), anemia/decreased hemoglobin (37.9%), decreased appetite (27.9%), transient increased aspartate transaminase/alanine aminotransferase (24.7%), constipation (24.7%), vomiting (22.1%), and diarrhea (21.1%).