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Petosemtamab Receives FDA Breakthrough Therapy Designation: Head / Neck Cancers

The FDA has granted breakthrough therapy designation to petosemtamab in recurrent or metastatic head and neck squamous cell carcinoma.

“We are excited and encouraged to receive breakthrough therapy designation for petosemtamab, which further validates its potential to become a new standard of care for patients with previously treated HNSCC,” Ashley Pereira, PharmD, senior vice president of Regulatory Affairs at Merus, stated in a news release. The study enrolled patients with histologically or cytologically confirmed solid tumors with evidence of metastatic or locally advanced disease that was not amenable to standard, curative-intent therapy. Accessed May 13, 2024. https://www.globenewswire.com/news-release/2024/05/13/2880374/37568/en/Petosemtamab-granted-Breakthrough-Therapy-Designation-by-the-U-S-FDA.html Cohen EEW, Fayette J, Daste A, et al. Clinical activity of MCLA-158 (petosemtamab), an IgG1 bispecific antibody targeting EGFR and LGR5, in advanced head and neck squamous cell carcinoma (HNSCC).

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