Posted by Michael Wonder on 27 Jul 2020
Checkmate Pharmaceuticals granted FDA fast track designation for CMP-001 combined with PD-1 blockade in the treatment of certain types of metastatic or unresectable melanoma
27 July 2020 - Checkmate Pharmaceuticals today announced that the U.S. FDA granted fast track designation to its product candidate, CMP-001, a differentiated Toll-like receptor 9 agonist, in combination with a programmed death receptor 1 blocking antibody (nivolumab or pembrolizumab) for two development programs, including:
- initial treatment of patients with unresectable stage III or stage IV melanoma to prolong the time to disease progression; and
- treatment of patients with unresectable or metastatic melanoma refractory to prior anti-PD-1 blockade to improve the overall tumour response rate.
The FDA previously granted orphan drug designation to CMP-001 for stages IIb-IV melanoma.
