The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for subcutaneous Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as a monotherapy for adults with advanced head and neck squamous cell carcinoma.

FDA Designation

The designation covers patients with cancer that is recurrent or metastatic and human papillomavirus (HPV)-unrelated after disease progression on or after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.

Johnson & Johnson’s (NYSE:JNJ) announced Tuesday that Rybrevant Faspro is approved in multiple settings for locally advanced or metastatic non-small cell lung cancer and is also being evaluated in additional solid tumors, including colorectal cancer.

The BTD is supported by data from the open–label Phase 1b/2 OrigAMI–4 study. Results were presented at the 2025 European Society for Medical Oncology (ESMO) Congress and demonstrate promising clinical activity, with rapid and durable responses, in a heavily pretreated patient population.

Subcutaneous amivantamab is being further evaluated in the ongoing Phase 3 OrigAMI-5 study, which is assessing the subcutaneous formulation of amivantamab in combination with Merck & Co. Inc.’s (NYSE:MRK) Keytruda (pembrolizumab) and carboplatin versus 5-fluorouracil (5FU) plus pembrolizumab and platinum-based chemotherapy (cisplatin or carboplatin) for HPV-unrelated recurrent or metastatic head and ...