Posted by Michael Wonder on 19 Dec 2018
Lynparza approved by US FDA for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer
19 December 2018 - AstraZeneca and MSD’s Lynparza reduced the risk of disease progression or death by 70% compared to placebo following response to platinum-based chemotherapy.
AstraZeneca and Merck today announced that the US FDA has approved Lynparza for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy, as detected by an FDA-approved companion diagnostic test.
This is the first regulatory approval for a PARP inhibitor in the 1st-line maintenance setting for BRCAm advanced ovarian cancer. The approval was based on positive results from the pivotal Phase III SOLO-1 trial in which 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 (HR 0.30 [95% CI 0.23-0.41], p<0.0001) compared to placebo following platinum-based chemotherapy. The safety profile of Lynparza was consistent with previous trials.
