J&J's Rybrevant Faspro receives FDA accelerated approval for recurrent or metastatic head and neck cancer

The FDA has granted accelerated approval to Johnson & Johnson's Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that has progressed on or after platinum-based chemotherapy and immunotherapy. This marks the first new drug approval for this patient population in 10 years and extends Rybrevant's indications beyond lung cancer. The approval is based on data from the phase 1b/2 OrigAMI-4 trial, which showed a 42% overall response rate.