Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) receives US FDA breakthrough therapy designation for patients with advanced head and neck cancer

Johnson & Johnson

18 February 2026 - Johnson & Johnson today announced that the US FDA has granted breakthrough therapy designation for subcutaneous amivantamab and hyaluronidase-lpuj as a monotherapy for the treatment of adults with head and neck squamous cell carcinoma that is recurrent or metastatic and human papillomavirus unrelated after disease progression on or after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. 

Rybrevant Faspro is approved in multiple settings for the treatment of locally advanced or metastatic non-small cell lung cancer and is also being evaluated in additional solid tumours, including colorectal cancer.

Read Johnson & Johnson press release

Michael Wonder

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Michael Wonder