The FDA granted priority review to a supplemental new drug application that seeks approval of olaparib tablets for maintenance therapy of women with newly diagnosed BRCA-mutated advanced ovarian cancer.
The designation applies to use of the agent for women who are in complete or partial response after first-line standard platinum-based chemotherapy.
The FDA is expected to make a decision on the application in the first quarter of 2019.
Olaparib (Lynparza; AstraZeneca, Merck) — a poly(ADP-ribose) polymerase inhibitor — is approved for maintenance treatment of women with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
If the new indication is approved, olaparib would become the first PARP inhibitor approved for use in the first-line maintenance setting of advanced ovarian cancer.
The FDA based the priority review designation on results from the randomized phase 3 SOLO-1 trial, which included 391 women with newly diagnosed BRCA-mutated advanced ovarian cancer who were in clinical complete or partial response to platinum-based chemotherapy.
Researchers randomly assigned the women 2:1 to maintenance therapy with olaparib tablets — dosed at 300 mg twice daily — or placebo. Treatment continued for up to 2 years or until disease progression.
Investigator-assessed PFS served as the primary endpoint. Secondary endpoints included time to second disease progression or death, time to first subsequent treatment and OS.
Median follow-up was 41 months.
Women assigned olaparib achieved significantly longer median PFS (not reached vs. 13.8 months; HR = 0.3; 95% CI, 0.23-0.41).
PFS rates at 36 months were 60% for the olaparib group and 27% for the placebo group.