By Estel Grace Masangkay
AstraZeneca reported that it has received the positive opinion of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the marketing authorization of Lynparza (olaparib) as monotherapy and maintenance treatment of advanced ovarian cancer in adult patients.
Olaparib is an investigational and potentially first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that induces cancer cell death by halting the reparation of damaged DNA in tumor cells. The company said that olaparib’s mechanism of action offers potential clinical activity in a range of tumor types with deficiencies in DNA repair.
The British big pharma is seeking approval for olaparib as treatment for platinum sensitive relapsed BRCA-mutated high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that is either completely or partially responsive to platinum-based chemotherapy. Olaparib is also undergoing evaluation in Phase 3 studies for gastric cancer and breast cancer in addition to ovarian cancer.
The CHMP’s positive recommendation was supported by results from a Phase 2 clinical trial, Study 19, which showed that olaparib significantly lengthened progression free survival (PFS) in patients with BRCA-mutated ovarian cancer versus placebo (median PFS 11.2 months versus 4.3 months respectively).
Briggs Morrison, EVP of Global Medicines Development and CMO at AstraZeneca, said, “We are delighted that the CHMP has recommended Lynparza as a first-in-class treatment option for women with BRCA-mutated ovarian cancer and we look forward to the European Commission’s decision once it completes its review. We are committed to investigating the full potential of olaparib and have a number of studies underway in multiple tumor types, including breast and gastric cancer.”
Harpal Kumar, Chief Executive of Cancer Research UK, commented, “We’re delighted that olaparib has received a positive opinion from the CHMP, particularly given the early role Cancer Research UK scientists played in discovering and developing PARP inhibitors as a new generation of drugs that exploit the weaknesses cancer cells have in repairing damaged DNA.”
Earlier this year, the drug was up before an advisory panel to the U.S. Food and Drug Administration (FDA). According to Bloomberg, the committee voted 11-2 this summer that the drug be investigated in a study to confirm its benefit before being approved.