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

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

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

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

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Outlook India

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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