New drug application for AstraZeneca’s Lynparza given more time by FDA

AstraZeneca and its US collaborator, Merck, have announced that the FDA is allowing more time for the review of the new drug application for their cancer drug, Lynparza. They have shared that the FDA plans to extend the Prescription Drug User Fee Act (PDUFA) date by three months, so there is extra time for a full review of the drug.

Lynparza is intended to be used in combination with abiraterone and prednisone or prednisolone in order to treat metastatic castration-resistant prostate cancer (mCRPC). AstraZeneca and Merck plan to continue to work alongside the FDA towards to approval of the drug.

The drug application draws on results from the PROpel phase 3 trial, which were published in June 2022 in NEJM Evidence. The FDA granted the application priority review in August 2022, and in November the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of Lynparza in combination with abiraterone and prednisone or prednisolone in the EU to treat adult patients with mCRPC when chemotherapy is not clinically recommended.

The drug combination is also undergoing regulatory reviews in various other countries, according to a press release published by AstraZeneca.

The drug is already approved in the EU for the treatment of fast-growing cancers of the ovaries, fallopian tubes, and peritoneum; HER2-negative breast cancer; pancreatic cancer; and metastatic prostate cancer, however all of these uses depend on specific requirements being met by the patient.

Betsy Goodfellow