AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the marketing authorisation of Lynparza™ (olaparib) as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the marketing authorisation of Lynparza™ (olaparib) as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Olaparib is a poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells.
Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer 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 tumour types including breast and gastric cancer.”
The positive CHMP opinion was based on the results from Study 191, a Phase II clinical trial that evaluated the efficacy and safety of olaparib compared to placebo in platinum sensitive relapsed high-grade serous ovarian cancer patients. The study showed that olaparib maintenance therapy significantly prolonged progression free survival (PFS) compared with placebo in patients with BRCA-mutated ovarian cancer– median PFS 11.2 months versus 4.3 months (PFS HR=0.18; 95% CI 0.10–0.31; p<0.0001). The most common adverse events associated with olaparib monotherapy to date were generally mild to moderate and included nausea, vomiting, fatigue and anaemia.
Harpal Kumar, Chief Executive, Cancer Research UK, said: “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. If approved, olaparib could offer new hope to women with advanced ovarian cancer and this illustrates how our partnerships with AstraZeneca are helping us to accelerate our efforts to beat cancer through new treatments for patients.”
The CHMP’s positive opinion on olaparib will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. The final decision will be applicable to all 28 European Union member countries plus Iceland, Norway and Liechtenstein. If approved, Lynparza will be the first PARP inhibitor available in these markets for the treatment of platinum sensitive relapsed BRCA-mutated high-grade serous ovarian cancer.
