AstraZeneca and Merck & Co have announced that the European Medicines Agency (EMA) has approved Lynparza (olaparib) tablets for use 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.
The EU approval was based on two randomised trials, SOLO-2 and Study 19, which showed that Lynparza reduced the risk of disease progression or death for platinum-sensitive relapsed ovarian cancer patients compared to placebo.
Approximately half of women with high grade epithelial ovarian cancer are expected to have deficiencies in homologous recombination repair (HRR), an important DNA damage response (DDR) pathway. Mutations most often occur within one of the BRCA genes, however other gene mutations can also impact the HRR pathway. While there are currently no routine tests to identify patients with these deficiencies beyond BRCA mutations, responsiveness to platinum-based chemotherapy can predict sensitivity to PARP inhibition.
Lynparza, the first PARP inhibitor approved, was initially licensed in Europe as a capsule formulation for women with BRCA-mutated platinum-sensitive relapsed ovarian cancer. The new tablet formulation, which reduces dosing from eight capsules twice daily to two tablets twice daily, will now be available for a broader group of women with platinum-sensitive relapsed ovarian cancer.
Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, 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.”
Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “Working with AstraZeneca, we are able to bring this innovative, targeted treatment that helps delay progression of the disease to a broader group of women.”