Regulatory Affairs

EMA approves Lynparza tablets to treat platinum-sensitive relapsed ovarian cancer

PBR Staff Writer Published 09 May 2018

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.