AstraZeneca and Merck have announced the approval of Lynparza (olaparib) tablets by the European Medicines Agency (EMA) to treat platinum-sensitive relapsed ovarian cancer.
The approval covers a 300mg twice daily dose of the drug as a maintenance therapy for high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer in patients who are in complete or partial response to platinum-based chemotherapy, irrespective of BRCA status.
Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor and has been co-developed by AstraZeneca and Merck under a global strategic oncology alliance signed by the companies in July last year.
The drug was previously approved in Europe to be administered as a capsule for the treatment of BRCA-mutated platinum-sensitive relapsed ovarian cancer.
The tablet formulation of the drug reduces dosing from eight capsules twice daily to two daily tablets.
AstraZeneca executive vice-president and Oncology Business Unit head 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 is based on the results obtained from two randomised trials conducted in 295 and 265 platinum-sensitive relapsed ovarian cancer subjects, respectively.
The drug demonstrated a decreased risk of disease progression or death when compared to placebo.
Recently, another application was submitted to the EMA seeking approval of Lynparza tablets to treat patients with BRCA-mutated, HER2-negative metastatic breast cancer.