Lynparza Receives New Indication

December 19, 2018 – The U.S. FDA has approved a new indication for Lynparza® (olaparib), manufactured by AstraZeneca and Merck. The drug is now approved to provide maintenance treatment for adult patients who have deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced ovarian cancer (epithelial ovarian, fallopian tube, or primary peritoneal). Patients who receive Lynparza under this indication should be in complete or partial response to first-line platinum-based chemotherapy, as detected by an FDA-approved companion diagnostic test.

Ovarian cancer remains a leading cause of cancer-related death in women, with more than 295,000 new cases diagnosed in the United States in 2018. It accounted for 185,000 deaths in the same year, and has a five-year survival rate of only 19%. Once ovarian cancer is diagnosed, treatment is aimed at delaying progression for as long as possible, with the goal of achieving complete remission or cure and preserving patient quality of life.

In clinical studies, patients who received Lynparza had a 70% reduction in risk of death compared to patients who received a placebo. Both groups of patients were treated with plantinum-based chemotherapy and exhibited a complete or partial response to chemotherapy prior to beginning Lynparza or the placebo. Median progression-free survival (PFS) had not been reached for patients treated with Lynparza after a median 41 months of follow-up, compared to a median 13.8 months PFS for patients who receive the placebo. More than half (60%) of patients who received Lynparza remained progression-free after three years, versus just 27% of patients who received the placebo.

Lynparza first received FDA approval in 2014, and now has two indications for ovarian cancer.