Merus (MRUS) said Tuesday that petosemtamab in combination with pembrolizumab has received breakthrough therapy designation from the US Food and Drug Administration.
The combination therapy has been designated as the first-line treatment for adult patients with recurrent or metastatic programmed death-ligand 1 positive head and neck squamous cell carcinoma, according to updated data from an ongoing phase 1/2 trial, the company said.
Merus said that with the designation, it plans to hold discussions with the FDA about the company's goal of submitting a potential biologics license application.
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