AstraZeneca, Merck Announce FDA Approval of Prostate Cancer Drug

AstraZeneca and Merck say the FDA has approved their cancer drug Lynparza.
Publish date:

AstraZeneca  (AZN) - Get Report and Merck & Co  (MRK) - Get Report said Wednesday that the U.S. Food and Drug Administration had approved their cancer drug Lynparza for patients with advanced prostate cancer.

Shares of AstraZeneca were up nearly 1% to $54.12 in pre-market trading, while Merck shares were up 1% to $78.35

The FDA approved the drug following a Phase III trial that determined the Lynparza treatment reduced the risk of disease progression or death by 66%.

The drug is intended to treat patients with a form of prostate cancer that could not be held back by standard hormone therapy.

Prostate cancer is the second most common cancer in men, the companies said in a statement, and five-year survival remains low, despite an increase in the number of available therapies.

"Prostate cancer has lagged behind other solid tumors in the era of precision medicine," Dr. Maha Hussain, a principal investigator of the drug's Phase 3 trial, and deputy director of the Robert H. Lurie Comprehensive Cancer Center, said in a statement.

Lynparza leads a class of drugs known as PARP inhibitors, which keep cancer cells damaged by chemotherapy from repairing themselves.

AstraZeneca said it will get a regulatory milestone payment of $35 million from MSD Laboratories following approval for Lynparza in the U.S. The payment is expected to be recorded as collaboration revenue in its second-quarter result.

The therapy was initially approved as an ovarian-cancer treatment.

Last month, AstraZeneca and the University of Oxford reportedly joined up to develop and manufacture a coronavirus vaccine, with the goal of producing as many as 100 million doses by the end of 2020, if it's proven to work.