AZ, Merck: Lynparza gets additional and braod approval in the US for ovarian cancer

AstraZeneca’s and Merck’s Lynparza new tablet’s formulation has been approved as maintenance treatment for women with platinum-sensitive recurrent ovarian cancer regardless of BRCA-mutation status, the companies said Friday.

AZ noted that Lynparza tablets also indicated in BRCA-mutated ovarian cancer beyond the third-line setting. Newly-approved tablet formulation means improved patient convenience.

On July 27, 2017, AstraZeneca and Merck announced a global strategic oncology collaboration to co-develop and co-commercialise AstraZeneca’s Lynparza, the world’s first and leading PARP inhibitor, and potential new medicine selumetinib, a MEK inhibitor, for multiple cancer types.

AstraZeneca and Merck on said that the US Food and Drug Administration (FDA) has granted approval for the PARP inhibitor, Lynparza (olaparib), and there are three major things to know:

For one, the new use of Lynparza as a maintenance treatment for recurrent, epithelial ovarian, fallopian tube or primary peritoneal adult cancer who are in response to platinum-based chemotherapy, regardless of BRCA status.

Furthermore, new use of Lynparza tablets (2 tablets twice daily) as opposed to capsules (8 capsules twice daily).

Also, Lynparza tablets now indicated (conversion from the current accelerated approval) for the use in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, AstraZeneca, said: “Physicians have almost three years of clinical experience with Lynparza on the market and we are now pleased to bring this important medicine, in a new tablet formulation, to a broader group of women. Today’s approvals validate more than 10 years of dedicated research behind Lynparza, the world’s first PARP inhibitor, which now provides oncologists with the greater flexibility for use in terms of treatment settings. It builds on our recently-announced collaboration with Merck, which aims to further increase the number of treatment options available to patients.”

Eric Pujade-Lauraine, Head of the Women Cancers and Clinical Research Department at Hôpitaux Universitaires Paris Centre, site Hôtel-Dieu, AP-HP and Principal Investigator of the SOLO-2 trial, one of the trials supporting the approval, said: “Today’s approval is welcome news for US patients with ovarian cancer, who are now able to benefit from treatment with olaparib irrespective of their BRCA-mutation status. This latest regulatory milestone underscores the breadth and depth of clinical data on olaparib, and not only demonstrates its efficacy as maintenance therapy, but adds to the data presented earlier this year showing sustained quality of life for patients undergoing treatment for this serious disease.”