The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to petosemtamab, an investigational bispecific antibody developed by Merus, for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in patients who have progressed following standard treatment.
Petosemtamab is engineered to simultaneously target EGFR (epidermal growth factor receptor) and LGR5, two proteins implicated in tumor growth and survival. By engaging both targets, the therapy aims to enhance anti-tumor activity and overcome resistance seen with conventional therapies.
This designation is based on promising early clinical data demonstrating notable anti-tumor responses in patients with advanced HNSCC who had limited options after disease progression.
Breakthrough Therapy Designation is intended to expedite the development and review of drugs that show substantial improvement over existing treatments for serious conditions. Head and neck squamous cell carcinoma is a challenging cancer to treat in its advanced stages and the approval highlights the urgent need for innovative therapies.
Merus plans to continue evaluating petosemtamab in ongoing clinical trials to confirm its safety and efficacy.
Disclaimer: This article is for informational purposes only and does not replace professional medical advice. Patients are advised to consult their healthcare providers regarding treatment decisions and clinical trial participation.
