FDA Grants Olaparib Breakthrough Designation in mCRPC

“Olaparib (Lynparza) has received an FDA breakthrough therapy designation as a treatment for patients with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer (mCRPC) in those who have received a prior taxane-based chemotherapy and at least either hormonal agent enzalutamide (Xtandi) or abiraterone acetate (Zytiga).

“The designation, which will accelerate the development and review of the first-in-class oral PARP inhibitor, is based on data from the phase II TOPARP-A trial that demonstrated that olaparib monotherapy had an overall response rate (ORR) of nearly 90% in a biomarker-defined subgroup of patients who had DNA-repair defects.


Trial Shows Benefit of 'BRCA-Targeting' Drug in Prostate Cancer

“Men with prostate cancer benefit from treatment with the pioneering drug olaparib – the first cancer drug to target inherited mutations – according to the results of a major trial presented today (Tuesday).

“Olaparib was licensed in December for women with ovarian cancer and inherited BRCA mutations, but the new research suggests it could also benefit men with genomic faults within their tumours.

“Researchers told the American Association of Cancer Research (AACR) conference in Philadelphia that up to 30 per cent of men with advanced prostate cancer had tumours with defects in repairing DNA – and these responded particularly well to olaparib.

“The men most likely to benefit could be identified by genetic testing to look for mutations in genes responsible for DNA repair – including the BRCA genes and the gene ATM.”