FDA to fast-track BioNTech’s BNT113 in HPV16+ head and neck cancer

German biotech BioNTech (Nasdaq: BNT) today announced that the US Food and Drug Administration (FDA) has granted fast track designation to BNT113, an investigational mRNA cancer immunotherapy, for the treatment of patients with human papillomavirus type 16 positive (HPV16+) head and neck squamous cell carcinoma (HNSCC) expressing PD-L1, a distinct cancer type associated by infection with high-risk human papillomavirus.

The FDA fast track process is designed to facilitate the development and expedite the review of new drugs and vaccines that are intended to treat or prevent serious conditions and have the potential to address an unmet medical need. The designation has been granted based on preliminary safety and efficacy data from the ongoing pivotal Phase II/III AHEAD-MERIT clinical trial evaluating BNT113 in combination with pembrolizumab, Merck & Co’s (NYSE: MRK) mega-blockbuster drug Keytruda, versus pembrolizumab monotherapy as a first-line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1.

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