The FDA granted olaparib priority review for the maintenance treatment of patients with platinum-sensitive, relapsed ovarian cancer.
The new drug application for olaparib (Lynparza, AstraZeneca) — a PARP inhibitor — includes data from the phase 3 SOLO-2 trial, presented at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer. The trial included 295 patients with germline BRCA1 or BRCA2 mutations who had received at least two prior lines of platinum-based chemotherapy and were in complete or partial response. Researchers randomly assigned patients to receive 300 mg twice daily olaparib or placebo.
Results showed the trial met its primary endpoint of improvement in investigator-assessed PFS (median, 19.1 months vs. 5.5 months; HR = 0.3; 95% CI, 0.22-0.41). Olaparib also demonstrated improved PFS by blinded independent central review (median, 30.2 months vs. 5.5 months; HR = 0.25; 95% CI, 0.18-0.35).
Grade 3 adverse events occurred in 36.9% of patients treated with olaparib and 18.2% of patients treated with placebo. The safety profile appeared consistent with those observed with the approved capsule formulation of olaparib.
“If approved as a maintenance therapy for patients with advanced ovarian cancer, Lynparza tablets would help address the unmet medical need and limited treatment options for women living with this disease, and offer patients a potential reduced pill burden for Lynparza,” Andrew Coop, vice president of U.S. medical affairs, oncology, at AstraZeneca, said in a company-issued press release. “Additionally, the U.S. FDA filing acceptance shows how we are progressing the science behind Lynparza — the first PARP inhibitor approved in the United States more than 2 years ago — while also investigating Lynparza in other tumor types, including breast, pancreatic and prostate.”
Olaparib tablets are an investigational formulation not currently approved by the FDA. The capsule formulation is approved by the FDA as monotherapy in patients with BRCA–mutated ovarian cancer who have received three or more prior lines of chemotherapy.
The FDA is expected to make a decision on this drug application by the third quarter of 2017.