A New Option for Advanced Head and Neck Cancer: FDA Approves Rybrevant Faspro
People with head and neck cancer that returns or spreads after chemotherapy and immunotherapy have had very few good options. On November 5, 2026, the US Food and Drug Administration granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase) for this group. It is the first drug approved in 10 years for these patients after platinum-based chemotherapy (FDA).
Who it is for
The approval covers adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and a PD-1 or PD-L1 immunotherapy. It does not cover throat cancers linked to human papillomavirus (HPV) (FDA).
How it works
Rybrevant Faspro is a subcutaneous injection that targets two pathways at once, EGFR and MET, both key drivers of tumor growth in head and neck cancer. It is the first dual-targeted therapy approved in this setting (Johnson & Johnson). The drug was already approved for certain lung cancers.
The results behind the approval
In a trial of 102 patients:
- 42% saw their tumors shrink or disappear, compared with about 20% or less for currently approved therapies (FDA).
- 15% had a complete response, meaning no detectable tumor on scans (MedPage Today).
- 56% of people who responded stayed in response for six months or longer.
What “accelerated approval” means
Accelerated approval lets the FDA approve drugs for serious diseases based on early signals, such as tumor shrinkage, before long-term survival data are available. The agency requires confirmatory studies, and the company must complete the ongoing Phase 3 OrigAMI-5 trial (FDA).
Side effects to know about
The prescribing information includes warnings about allergic and administration reactions, lung inflammation, skin reactions, eye problems and harm to an unborn baby (MedPage Today).
The bottom line
For patients with advanced, previously treated head and neck cancer, this approval more than doubles the response rate seen with older options. If you or a loved one is in this situation, ask your oncologist whether you are a candidate.