AstraZeneca's prostate cancer drug gets US priority review

The supplemental new drug application is for Lynparza in combination with other drugs to treat adult patients with metastatic castration-resistant prostate cancer (mCRPC).

Lynparza is being jointly developed and commercialised by AstraZeneca and MSD.

The US Food and Drug Administration (FDA) grants priority review to applications for medicines that offer significant advantages over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance, AstraZeneca said.

A regulatory decision is expected during the fourth quarter of 2022.

“In the US, prostate cancer is the second most common cancer in male patients and is projected to cause approximately 35,000 deaths in 2022. Overall survival for patients with mCRPC is approximately three years in clinical trial settings, and even shorter in the real world,” the company said.

“Approximately half of patients with mCRPC may receive only one line of active treatment, with diminishing benefit of subsequent therapies.”

Reporting by Frank Prenesti at Sharecast.com