FDA grants Priority Review to RYBREVANT FASPRO in head and neck cancer

The FDA granted Priority Review to the supplemental application for subcutaneous RYBREVANT FASPRO in recurrent or metastatic head and neck squamous cell carcinoma that progressed after platinum chemotherapy and a PD-1 or PD-L1 inhibitor. Priority Review targets a review of about six months, but no FDA action date was given. The filing rests on the single-arm Phase 1b/2 OrigAMI-4 study, which showed a 42% overall response rate.

• Priority Review for subcutaneous amivantamab and hyaluronidase-lpuj
• OrigAMI-4 monotherapy overall response rate 42%
• Review timeline of about six months; no action date given