European Commission approves Lynparza + Avastin as first line maintenance treatment of ovarian cancer.- AstraZeneca + Merck Inc.

Olaparib (Lynparza) in combination with bevacizumab (Avastin) from AstraZeneca and Merck Inc., has been approved in the European Union as a first-line maintenance treatment for adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer.. The patients included are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab whose cancer is associated with homologous recombination deficiency (HRD)-positive status. “Half of all newly diagnosed patients with advanced ovarian cancer have HRD-positive tumors,” Dave Fredrickson, executive vice president of AstraZeneca, said in a press release. “Women treated with Lynparza in combination with bevacizumab in the PAOLA-1 Phase III trial lived progression free for a median of more than three years, showing that HRD testing should be an essential component of clinical diagnosis. HRD status can help physicians select a personalized first-line treatment regimen for patients to substantially delay relapse in this devastating disease.” The combination’s approval was based on data from a biomarker subgroup analysis of the PAOLA-1 phase III trial. The data showed that the combination of olaparib with bevacizumab demonstrated a progression-free survival (PFS) benefit compared to bevacizumab alone for patients with HRD-positive advanced ovarian cancer.