FDA grants accelerated approval to Rybrevant Faspro for head and neck cancer

The U.S. Food and Drug Administration granted accelerated approval on November 05, 2026 to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody.¹ The drug is made by Janssen Biotech, Inc., as named in the approval.

Rybrevant Faspro is not indicated as a treatment for patients with oropharyngeal squamous cell carcinoma that is associated with human papillomavirus (HPV).²

The FDA said this marks the first approval in 10 years of a drug for patients with recurrent or metastatic HNSCC who had received prior platinum-based chemotherapy.² The agency's Oncology Center of Excellence director, Angelo De Claro, M.D., called it "a meaningful step forward for patients with head and neck squamous cell carcinoma, a disease where treatment options have historically been limited and outcomes remain poor."²

The approval relied on surrogate endpoints under the agency's accelerated pathway. Accelerated approval of Rybrevant Faspro was granted based on overall response rate and duration of response.² Since it is not yet confirmed whether this will translate into a clinically meaningful benefit in long-term outcomes, the FDA has required confirmatory studies to verify and describe clinical benefit.²

In the supporting trial, an open-label, multicenter clinical trial involving 102 patients with recurrent or metastatic HNSCC, Rybrevant Faspro had an overall response rate of 42%, meaning these patients saw their tumor either decrease in size or disappear.² Of those patients who had a response, 56% had a response lasting six months or longer.² By comparison, currently approved therapies are associated with an overall response rate of around 20% or less and poor outcomes.²

The prescribing information for use as a single agent includes warnings and precautions for hypersensitivity and administration-related reactions, interstitial lung disease (ILD)/pneumonitis, dermatologic adverse reactions, ocular toxicity, and harm to an unborn baby.² The FDA granted Rybrevant Faspro Breakthrough Therapy designation for this indication.²