FDA Approves Priority Review Voucher for AstraZeneca’s Imjudo

The FDA has determined that AstraZeneca’s Imjudo (tremelimumab), approved to treat adults with unresectable liver cancer, meets the agency’s criteria for redeeming a priority review voucher.

Imjudo is a monoclonal antibody treatment FDA-approved in combination with durvalumab for adults with unresectable hepatocellular carcinoma, the most common form of liver cancer.

AstraZeneca purchased the priority review voucher from Sobi in August 2019 for $95 million.

Priority review vouchers can be sold to another company to redeem and receive FDA priority review. The agency is required to publish a notice of issuance of the vouchers as well as the approval of products redeeming a voucher.