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Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Title:

PDS Biotechnology Granted FDA Fast Track Designation for Lead Candidate PDS0101

Published date:
06/02/2022
Excerpt:
PDS Biotechnology Corporation (Nasdaq: PDSB)...today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). PDS0101 in combination with KEYTRUDA® is being studied in the VERSATILE-002 Phase 2, open-label, multicenter trial for the treatment of recurrent or metastatic HPV16-positive head and neck cancer in collaboration with Merck (known as MSD outside the US and Canada).