AstraZeneca and Merck have secured approval from the European Medicines Agency (EMA) for Lynparza tablets to treat patients with platinum-sensitive relapsed ovarian cancer.
The approval has been granted for Lynparza (olaparib) tablets (300mg twice daily) to be used as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, regardless of BRCA status.
Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor that can exploit tumour DDR-pathway dependencies to preferentially kill cancer cells.
In July 2017, AstraZeneca collaborated with Merck to co-develop and co-commercialise Lynparza, which is claimed to be the world’s first PARP inhibitor.
AstraZeneca oncology business unit head and executive vice president Dave Fredrickson said: ‘With this new approval for Lynparza, we will now be able to offer more women with platinum-sensitive ovarian cancer, regardless of their BRCA status, a chance to achieve long-term disease control with an oral medicine that has a well-characterised safety and tolerability profile.”
The approval was based on two randomised trials, Solo-2 and Study 19, which demonstrated that Lynparza decreased the risk of disease progression or death for platinum-sensitive relapsed ovarian cancer patients compared against placebo.
Solo-2 is a randomised, double-blinded and multicentre trial designed to assess the efficacy of Lynparza tablets compared against placebo as maintenance monotherapy in patients with platinum-sensitive relapsed or recurrent germline BRCA-mutated ovarian, fallopian tube and primary peritoneal cancer.
The trial recruited 295 patients with documented germline BRCA1 or BRCA2 mutations who had received at least two prior lines of platinum-based chemotherapy and were in complete or partial response.
Study 19 is a randomised, double-blinded, placebo-controlled, multi-centre trial designed to assess the efficacy and safety of Lynparza compared against placebo in relapsed, high-grade serous ovarian cancer patients.
The study enrolled 265 patients regardless of BRCA mutation status and who had completed at least two courses of platinum-based chemotherapy and their most recent treatment regimen.