G1 Therapeutics receives FDA acceptance of its Small Cell Lung Cancer NDA
G1 Therapeutics Inc. (GTHX) reported that the FDA has accepted its New Drug Application of its lead drug candidate, Trilaciclib. The FDA has given Priority Review status to the NDA, and the PDUFA action date has been fixed at February 15, 2021. The drug candidate is a first-in-class investigational therapy aiming to safeguard the bone marrow and immune system of patients during chemotherapy. The NDA pertains to its use in patients suffering from small cell lung cancer.
G1 Therapeutics has supported