AstraZeneca and MSD have announced that a supplemental New Drug Application for Lynparza (olaparib) has been accepted and granted Priority Review in the US for patients with metastatic castration-resistant prostate cancer (mCRPC) and deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutations, who have progressed following prior treatment with a new hormonal agent.
A Prescription Drug User Fee Act (PDUFA) date is set for the second quarter of 2020.
The Priority Review by the US Food and Drug Administration (FDA) is based on results from the Phase III PROfound trial, which were presented during the Presidential Symposium at the 2019 European Society of Medical Oncology congress. Results of the PROfound trial showed Lynparza significantly reduced the risk of disease progression or death by 66% based on a hazard ratio of 0.34 (p<0.0001) vs. abiraterone or enzalutamide in patients with BRCA1/2 or ATM-mutated mCRPC, the primary endpoint of the trial.
The trial also showed that Lynparza reduced the risk of disease progression or death by 51% based on a hazard ratio of 0.49 (p<0.0001) vs. abiraterone or enzalutamide in the overall trial population of patients with HRR-mutated (HRRm) mCRPC (those with mutations in the genes for BRCA1/2, ATM, CDK12 or 11 other HRRm genes; key secondary endpoint). The safety and tolerability profile of Lynparza in the PROfound trial was in line with that observed in previous clinical trials.