AstraZeneca’s Lynparza backed for approval by EMA committee

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization of Anglo-Swedish pharma major AstraZeneca’s (LSE: AZN) Lynparza (olaparib).

The drug is recommended 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.”

Earlier this year, a US Food and Drug Administration advisory panel gave a negative assessment on olaparib, and a final decision from the agency is still expected. AstraZeneca has said sales of olaparib could reach $2 billion a year, although some Wall Street analysts see sales at less than half that amount.