Treadwell Therapeutics announced that the FDA has granted Fast Track Designation to CFI-402257, a best in class inhibitor of Threonine Tyrosine Kinase (TTK, also known as Mps1), for the treatment of adult patients with ER+/HER2- advanced breast cancer after disease progression on prior CDK4/6 inhibitors and endocrine therapy, both as a monotherapy and in combination with fulvestrant.
"There is an urgent need for new, safe and efficacious therapies to treat ER+/HER2- breast cancer, particularly when standard of care regimens fail," said Dr. Mark Bray, Treadwell CSO and Co-founder. "CFI-402257 has shown early signs of durable activity with a manageable safety profile, as a monotherapy and in combination with fulvestrant in ER+/HER2- breast cancer patients that have failed CDK4/6 inhibitors. We are thankful for the Fast Track Designation granted by the FDA and look forward to the continued development of CFI-402257 in ER+/HER2- breast cancer."
Fast Track designation seeks to streamline the development and accelerate the review of new agents with potential to treat serious or life-threatening diseases and that potentially address an unmet medical need. Drugs that are granted this designation can have more frequent interactions with the FDA, as well as potential pathways for expedited approval.
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