Merus Carcinoma Treatment Awarded US FDA's Breakthrough Therapy Designation
By Dean Seal
Merus said federal regulators have granted breakthrough therapy designation to its carcinoma treatment petosemtamab.
The clinical-stage oncology company said Monday that the Food and Drug Administration's special status was granted to petosemtamab for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma, and whose disease has progressed following treatment with platinum-based chemotherapy and other treatments.
The breakthrough therapy designation is designed by the FDA to expedite the development and evaluation of treatments for serious or life-threatening conditions if they have preliminary clinical evidence showing substantial improvement at certain endpoints over currently available therapies.
The treatment has already received the FDA's fast-track designation, another special status meant to expedite development.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
May 13, 2024 08:53 ET (12:53 GMT)
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