Posted by Michael Wonder on 17 Apr 2023
Candel Therapeutics receives FDA fast track designation for CAN-2409 in non-small-cell lung cancer
17 April 2023 - Fast track designation has the potential to facilitate the development and expedite the US FDA review of CAN-2409 plus valacyclovir and anti-PD1 antibodies in patients with stage III/IV non-small cell lung cancer who are resistant to first line PD-(L)1 inhibitor therapy and who do not have molecular driver mutations.
Candel Therapeutics today announced that the US FDA granted fast track designation for its lead asset CAN-2409, an investigational viral immunotherapy, plus valacyclovir in combination with pembrolizumab in order to improve survival or delay progression in patients with stage III/IV non-small cell lung cancer who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy.
