Posted by Michael Wonder on 09 May 2020
Lynparza (olaparib) approved by FDA as first-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer
8 May 2020 - Improved the median time to disease progression (37.2 months) vs. bevacizumab alone (17.7 months) following response to platinum-based chemotherapy with bevacizumab.
AstraZeneca and Merck today announced that the U.S. FDA has approved Lynparza in combination with bevacizumab as a first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Patients will be selected for therapy based on an FDA-approved companion diagnostic for Lynparza.
The approval was based on a biomarker subgroup analysis of 387 patients with HRD-positive tumours from the Phase 3 PAOLA-1 trial, which showed that Lynparza in combination with bevacizumab reduced the risk of disease progression or death by 67% (HR 0.33 [95% CI, 0.25-0.45]). It improved progression-free survival to a median of 37.2 months vs. 17.7 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer.
