FDA Approves Amivantamab and Hyaluronidase for Metastatic HNSCC

The FDA granted Johnson & Johnson's Rybrevant Faspro accelerated approval for treating recurrent or metastatic head and neck cancer. This is the first such approval in 10 years. The therapy targets EGFR and MET pathways, showing a 42% overall response rate in trials. JNJ shares were up 0.25% at $272.99 on Friday.

FDA approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) by Johnson & Johnson for recurrent or metastatic head and neck squamous cell carcinoma. Trial data showed 42% tumor response rate. Continued approval depends on confirmatory trial results. Common side effects include rash, fatigue, and nail problems.

FDA granted accelerated approval to Johnson & Johnson's RYBREVANT FASPRO for head and neck cancer treatment. The drug, co-formulated with Halozyme's ENHANZE technology, targets specific receptors. Halozyme (HALO) licenses its technology to multiple pharmaceutical companies. The therapy was previously approved for lung cancer.

FDA granted accelerated approval to Johnson & Johnson's RYBREVANT FASPRO for advanced head and neck cancer, expanding its use beyond lung cancer. Halozyme's ENHANZE technology enables subcutaneous delivery. According to Halozyme, this approval addresses a high unmet need. The approval was announced on November 5, 2026.

The FDA approved J&J's Rybrevant Faspro for certain head and neck cancer patients, its first approval beyond lung cancer. The accelerated approval follows Phase Ib/II trial results showing a 42% overall response rate. J&J aims for $50bn in annual oncology sales by 2030, with Rybrevant as a key driver. GlobalData forecasts $2.6bn in 2030 sales for Rybrevant, excluding the new indication.

Johnson & Johnson (JNJ) received FDA accelerated approval for RYBREVANT FASPRO to treat recurrent or metastatic head and neck cancer. The approval, based on a trial with a 42% response rate, expands the drug's use beyond lung cancer. The approval is subject to further clinical trial confirmation.