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.
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