EMA Advisory Committee Recommends AstraZeneca’s Cancer Drug LynparzaBy
AstraZeneca reports the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the marketing authorization of Lynparza (olaparib), a drug to treat BRCA-mutated ovarian cancer. The recommendation was for the drug’s use as a 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.
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 (EU). The final decision will be applicable to all 28 EU 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.
Olaparib is an oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumor DNA repair pathway deficiencies to preferentially kill cancer cells. Olaparib is currently being investigated in Phase III trials for the treatment of BRCA-mutated ovarian cancer patients who are in complete or partial response following platinum-based chemotherapy in the relapsed and first-line settings and is one of a number of compounds being investigated by AstraZeneca for ovarian cancer. Phase III studies in gastric cancer and adjuvant and metastatic BRCAm breast cancers are also underway.