FDA grants priority review to Lynparza regimen for advanced prostate cancer
The FDA granted priority review to olaparib as part of combination therapy treatment of metastatic castration-resistant prostate cancer.
Olaparib (Lynparza; AstraZeneca, Merck) is a poly(ADP-ribose) polymerase (PARP) inhibitor approved in the United States for multiple cancer indications.
The priority review designation — which applies to use of the agent in combination with abiraterone acetate and prednisone or prednisolone — is based on results of the randomized phase 3 PROpel study.
The study included 796 men undergoing first-line treatment for metastatic castration-resistant disease after primary androgen deprivation therapy failure.
Researchers randomly assigned men to 1,000 mg once-daily abiraterone acetate plus 5 mg twice-daily prednisone or prednisolone with either 300 mg twice-daily olaparib (n = 399) or placebo (n = 397).
Investigator-assessed radiographic PFS served as the primary endpoint. Secondary endpoints included OS.
Results — presented in February at ASCO Genitourinary Cancers Symposium — showed significantly longer radiographic PFS among men assigned the olaparib regimen (median, 24.8 months vs. 16.6 months; HR = 0.66, 95% CI, 0.54-0.81) regardless of whether they had mutations in HRR-associated genes detected through circulating tumor DNA testing.
Olaparib exhibited a safety profile consistent with that observed in prior clinical trials.
“There remains a critical unmet need among patients diagnosed with metastatic castration-resistant prostate cancer, where the prognosis remains poor and treatment options are limited,” Susan Galbraith, MBBCHIR, PhD, MRCP, FRCR, FMedSci, executive vice president for oncology research and development with AstraZeneca, said in a company-issued press release. “[This] news is another step [toward] bringing forward a new, much-needed treatment option in this setting. If approved, Lynparza with abiraterone will become the first combination of a PARP inhibitor and a new hormonal agent for patients with this disease.”
The FDA is expected to make a decision on approval for this indication during the fourth quarter of this year.