Werewolf Therapeutics Receives FDA Fast Track Designation for WTX124 in Advanced Melanoma
Reuters
Oct 08
Werewolf Therapeutics Receives FDA Fast Track Designation for WTX124 in Advanced Melanoma
Werewolf Therapeutics Inc. has received Fast Track Designation from the U.S. FDA for WTX-124, its investigational therapy for the potential treatment of patients with locally advanced or metastatic cutaneous melanoma after standard of care immunotherapy. This designation, which highlights the promise of the company's INDUKINE™ platform, is intended to expedite the development and review of drugs addressing serious unmet medical needs. The decision was based on data showing clinically meaningful anti-tumor activity and a tolerable safety profile in melanoma patients previously treated with immune checkpoint inhibitors. Fast Track status enables more frequent engagement with the FDA and could facilitate an accelerated approval process for WTX-124. No other organizations were reported as recipients of this regulatory designation.
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