FDA grants fast track status to Cosela for triple-negative breast cancer
The FDA granted fast track designation to trilaciclib for use in combination with chemotherapy for treatment of locally advanced or metastatic triple-negative breast cancer, according to the agent’s manufacturer.
Trilaciclib (Cosela, G1 Therapeutics), a cyclin dependent kinase 4/6 inhibitor, is approved in the United States to reduce frequency of chemotherapy-related bone marrow suppression among adults with extensive-stage small cell lung cancer.
The randomized phase 3 PRESERVE 2 trial is underway to assess trilaciclib among patients receiving first- or second-line gemcitabine and carboplatin chemotherapy for triple-negative breast cancer.
“Fast track designation underscores the urgent need for innovative drugs that can significantly improve [outcomes for patients with triple-negative breast cancer],” Raj Malik, MD, chief medical officer at G1 Therapeutics, said in a company-issued press release. “It provides an important pathway to help expedite the development and regulatory review of Cosela in this indication. We look forward to working closely with the FDA as we advance this pivotal program in triple-negative breast cancer and continue to work to unlock the broader potential of this pipeline-in-a-molecule compound that we hope will help patients across multiple tumor types.”
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