08/17/2017

FDA  granted approval for the PARP inhibitor, LYNPARZA® (olaparib)

The FDA  granted approval for the PARP inhibitor, LYNPARZA^® (olaparib), as follows:

• New use of LYNPARZA tablets as a maintenance treatment of adult patients with recurrent, epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, regardless of BRCA status
• New use of LYNPARZA tablets (2 tablets twice daily) as opposed to capsules (8 capsules twice daily)
• LYNPARZA tablets also now indicated (conversion from the current accelerated approval) for the use in adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCA) advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy; patients for this indication are selected for therapy based on an FDA-approved companion diagnostic.

While LYNPARZA tablets are approved for both indications, LYNPARZA capsules (400mg twice daily) will still be available through a limited specialty pharmacy network for patients being treated in the late-line setting. LYNPARZA capsules are not indicated for maintenance treatment.

For more information, click here.