Olaparib to treat BRCA-mutated ovarian cancerFebruary 5, 2019
Olaparib has been given the nod by US FDA for use as maintenance treatment of adult patients with deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.
Patients with gBRCAm advanced epithelial ovarian, fallopian tube or primary peritoneal cancer are selected for therapy based on an FDA-approved companion diagnostic for olaparib.
This is the first regulatory approval for a PARP inhibitor in a first-line maintenance setting for BRCAm advanced ovarian cancer, according to AstraZeneca and MSD.
The approval was based on positive results from the pivotal Phase 3 SOLO-1 trial in which olaparib (Lynparza) reduced the risk of disease progression or death by 70 percent in patients with BRCAm advanced ovarian cancer who were in complete or partial response to platinum-based chemotherapy compared to placebo.
In the SOLO-1 trial, with median of 41 months of follow-up, the median progression-free survival for patients treated with olaparib was not reached compared to 13.8 months for patients treated with placebo. In the trial, 60 percent of patients receiving olaparib remained progression-free at three years, compared to 27 percent of patients receiving placebo.