European Commission approved Lynparza for metastatic pancreatic cancer
AstraZeneca and Merck have announced that they have received the approval of Lynparza (Olaparib) for germline BRCA-mutated metastatic pancreatic cancer in Europe. The drug is indicated for adult patients with germline BRCA1/2 mutated metastatic adenocarcinoma of the pancreas.
Lynparza is indicated for patients whose disease has not progressed after a minimum of 16-weeks of treatment with platinum-based chemotherapy.
The approval is based on the Phase 3 POLO trial, a randomized, double-blind, placebo-controlled trial. Patients were randomly assigned in a ratio of 3:2 and were treated with Lynparza and placebo. Progression-free survival was considered as the primary endpoint. The median progression-free survival was 7.4 months in the Olaparib group compared to 3.8 months in patients who were on placebo. At the interim analysis, no difference was observed in the overall survival. Also, no improvement in the quality of life was observed.
The safety profile of the drugs was consistent with the earlier indications.
Lynparza has been earlier approved in Europe for
Ovarian, fallopian, or primary peritoneal cancer
BRCA1/2-mutated HER2-negative locally advanced or metastatic breast cancer
Earlier AstraZeneca and Merck have entered strategic oncology collaboration to co-develop and co-commercialize AstraZeneca’s Lynparza (Olaparib). The drug is in the development of fourteen different cancers. Under this agreement, AstraZeneca and Merck agreed to share the costs for the co-development and co-commercialization of Lynparza.
Pancreatic cancer is the 12th most common cancer globally and is the seventh leading cause of death. Cancer doesn’t show symptoms and is usually diagnosed in the metastatic stages of the disease. A minimal set of patients (5-7%) with metastatic pancreatic cancer will have BRCA mutations.