G1 Therapeutics Reports the US FDA Acceptance and Priority Review of NDA for Trilaciclib to Treat SCLC

August 18, 2020 Auto Bot Acceptance, FDA, G1 Therapeutics, NDA, Pharma, Priority Review, regulatory, reports 0

Shots:

  • The NDA submission is based on three clinical studies in which Trilaciclib was administered prior to chemotherapy treatment in patients with SCLC and has demonstrated robust myelopreservation benefits. The company anticipates the PDUFA date as Feb 15, 2021
  • G1 is making Trilaciclib available to SCLC patients in the US, who are unable to enter clinical trials while the NDA for the therapy is under regulatory review, pursuant to FDA’s EAP
  • Trilaciclib is an investigational therapy designed to preserve bone marrow and immune system function during CT and improve patient outcomes and has received the US FDA’s BT designation in 2019

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