NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval for olaparib (AstraZeneca/Merck's Lynparza) as a first-line maintenance treatment in combination with bevacizumab (Genentech's Avastin) for certain patients with advanced, high-grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Patients must have received first-line platinum-based chemotherapy and have tumors characterized by homologous repair recombination deficiency (HRD) as determined by the presence of BRCA1/2 mutations or genomic instability.
CHMP based its decision on a biomarker subgroup analysis of the Phase III PAOLA-1 trial, published in the New England Journal of Medicine last December. In the study, the combination of olaparib and bevacizumab maintenance treatment reduced the risk of death or progression by 67 percent. HRD-positive patients had median progression-free survival of 37.2 months on the olaparib-bevacizumab maintenance regimen compared to 17.7 months on bevacizumab alone.
The European Commission will now review CHMP's opinion and decide whether to approve the regimen.
The US Food and Drug Administration approved the same indication in May. At the time, the agency also approved Myriad Genetics' MyChoice CDx as a companion diagnostic for identifying women with BRCA1/2 mutations or genomic instability, who are likely to benefit from the treatment.