FDA Grants Orphan Drug Designation to Cavrotolimod for Merkel Cell Carcinoma

Source: OncLive, March 2021

The FDA has granted an orphan drug designation to cavrotolimod (AST-008) for the treatment of patients with Merkel cell carcinoma (MCC), according to an announcement from Exicure, Inc.1

The spherical acid toll-line receptor 9 agonist was designed to activate the innate and adaptive immune systems to induce strong antitumor responses.

“We are excited to have been granted orphan drug designation by the FDA for cavrotolimod for MCC,” Douglas E. Feltner, MD, chief medical officer of Exicure, stated in a press release. “This designation marks significant progress toward our goal of fulfilling the unmet medical need and finding a treatment for [patients with] MCC.”