British-Swedish drug maker AstraZeneca has received positive feedback for its Lynparza (olaparib) from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
CHMP recommended the marketing authorisation of Lynparza as monotherapy to treat high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer.
Olaparib is a poly ADP-ribose polymerase (PARP) inhibitor, which exploits tumour DNA repair pathway deficiencies to selectively induce death of a cancer cell.
AstraZeneca global medicines development executive vice-president Briggs Morrison said: "We are delighted that the CHMP 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 CHMP positive opinion was based on the results from Study 19, a Phase II clinical trial that assessed the efficacy and safety of olaparib compared to a placebo in platinum sensitive relapsed high grade serous ovarian cancer patients.
The study demonstrated that olaparib maintenance therapy prolonged progression free survival (PFS) compared with a placebo in patients with BRCA-mutated ovarian cancer.
Cancer Research UK chief executive Harpal Kumar 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."
The European Commission will now review the CHMP’s positive opinion on olaparib.
Image: AstraZeneca’s research and development site in Mölndal, Sweden. Photo: courtesy of Erik031.
