Petosemtamab granted Breakthrough Therapy Designation by the U.S. FDA
“We are excited and encouraged to receive BTD for petosemtamab which further validates its potential to become a new standard of care for patients with previously treated HNSCC,” said Ashley Pereira, Pharm.D. SVP of Regulatory Affairs at Merus. “We look forward to continued constructive conversations with the FDA as we move forward in our plan to initiate a phase 3 trial in previously treated HNSCC mid-2024 and prepare for a potential phase 3 trial evaluating the combination of petosemtamab and pembrolizumab in previously untreated patients.”
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