The Priority Review

Approvals Brief

FDA approves RYBREVANT FASPRO for advanced head and neck cancer

The FDA granted accelerated approval to RYBREVANT FASPRO, a co-formulated amivantamab and hyaluronidase-lpuj, for adults with recurrent or metastatic head and neck squamous cell carcinoma that progressed after platinum-based chemotherapy and an anti-PD-(L)1 antibody. The approval excludes patients with HPV-associated oropharyngeal squamous cell carcinoma.

Primary source

Company press release (PR Newswire), November 6, 2026

U.S. FDA Approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Co-Formulated with Halozyme's ENHANZE® Technology for the Treatment of Advanced Head and Neck Cancer

Read the source: U.S. FDA Approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Co-Formulated with Halozyme's ENHANZE® Technology for the Treatment of Advanced Head and Neck Cancer prnewswire.com

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