FDA Grants Priority Review to sNDA for Lynparza
The FDA has granted a priority review for AstraZeneca and Merck’s supplemental New Drug Application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for treatment of adult patients with metastatic castration-resistant prostate cancer.
Lynparza is a PARP (poly adenosine diphosphate-ribose polymerase) inhibitor that prevents cancer cells from repairing.
The FDA grants a priority review for drugs that offer significant advantages over available options in terms of safety or efficacy, preventing serious conditions or enhancing patient compliance.
There is a critical unmet need among patients diagnosed with metastatic castration-resistant prostate cancer, where the prognosis remains poor and treatment options are limited, the company said.
The FDA is expected to issue a decision on the sNDA in the fourth quarter of this year.