G1 Therapeutics Gets Fast Track Designation for Breast Cancer Treatment
20 July 2021 - 12:03AM
Dow Jones News
By Chris Wack
G1 Therapeutics Inc. said the U.S. Food and Drug Administration
has granted fast track designation to Cosela trilaciclib
investigation for use in combination with chemotherapy for the
treatment of locally advanced or metastatic triple negative breast
cancer.
The company said Cosela is currently being evaluated in a Phase
3, placebo-controlled study in patients receiving first- or
second-line gemcitabine and carboplatin chemotherapy for triple
negative breast cancer.
Fast track is a process designed to facilitate the development
and expedite the review of drugs to treat serious conditions and
fill unmet medical needs. A drug that receives fast track
designation may be eligible for more frequent engagements with the
FDA to discuss the drug's clinical development plan, eligibility
for accelerated approval and priority review, and rolling
review.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
July 19, 2021 09:52 ET (13:52 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
G1 Therapeutics (NASDAQ:GTHX)
Historical Stock Chart
From Jul 2024 to Aug 2024
G1 Therapeutics (NASDAQ:GTHX)
Historical Stock Chart
From Aug 2023 to Aug 2024