FDA priority review for advanced head and neck cancer
Johnson & Johnson won FDA Priority Review for RYBREVANT FASPRO as a potential first-in-class subcutaneous EGFR/MET therapy in advanced head and neck cancer.
The sBLA targets adults with recurrent or metastatic HNSCC whose disease progressed on platinum chemotherapy and PD-1/PD-L1 treatment; FDA decision expected in about six months.
OrigAMI-4 data showed a 42% overall response rate for monotherapy, with more than one-third of responders achieving complete response.
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