FDA Grants Accelerated Approval to Rybrevant Faspro for Recurrent, Metastatic Head and Neck Cancer

The U.S. Food and Drug Administration on Thursday granted accelerated approval to Rybrevant Faspro for adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease has progressed after platinum-based chemotherapy and immunotherapy, offering a new option for a hard-to-treat group with few alternatives.

The approval, issued Nov. 5 to Janssen Biotech Inc., covers adults with recurrent or metastatic head and neck squamous cell carcinoma, or HNSCC, after standard treatment has failed. It does not include HPV-associated oropharyngeal squamous cell carcinoma. The FDA said the decision marks the first approval in about 10 years for patients with recurrent or metastatic HNSCC previously treated with platinum chemotherapy.

The decision was based on tumor response data from an open-label, multicenter cohort of the OrigAMI-4 study, not on a confirmed survival benefit. In 102 patients whose disease had progressed after prior PD-(L)1 inhibitor treatment and platinum chemotherapy, blinded independent central review found a 42% confirmed overall response rate. The complete response rate was 15%. According to the FDA, 56% of patients who responded had responses lasting at least six months.

Rybrevant Faspro is a subcutaneous formulation of amivantamab co-formulated with hyaluronidase, which enables it to be given as an injection under the skin rather than by intravenous infusion. Amivantamab was previously approved in lung cancer; this latest decision adds a new supplemental indication for the subcutaneous product.

The approval came through the FDA’s accelerated approval program, which allows drugs for serious conditions to reach patients earlier based on measures such as tumor shrinkage or response duration that are reasonably likely to predict clinical benefit. Under that pathway, confirmatory studies are required to verify that the treatment delivers a real clinical benefit, such as improved survival or other meaningful outcomes.

That distinction matters for patients and doctors weighing the news. Recurrent or metastatic HNSCC is an aggressive disease with poor outcomes, and treatment choices narrow sharply once the cancer stops responding to platinum chemotherapy and immune checkpoint inhibitors such as pembrolizumab or nivolumab. Those drugs changed care for advanced head and neck cancer in the mid-2010s, but options after both platinum treatment and PD-1 or PD-L1 therapy have remained limited.

“Today’s approval represents 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,” said Dr. Angelo De Claro, director of the FDA’s Oncology Center of Excellence. “This therapy offers patients and their physicians a new option with the potential to make a real difference in people’s lives.”

The drug’s label includes warnings for hypersensitivity and administration-related reactions, interstitial lung disease or pneumonitis, dermatologic adverse reactions, ocular toxicity, and embryo-fetal toxicity.

For now, the practical significance is straightforward: patients with previously treated recurrent or metastatic HNSCC now have a newly authorized option after platinum chemotherapy and immunotherapy have failed. But because the approval is accelerated and based on response data from a single-arm study, follow-up trials will need to confirm whether those tumor responses translate into verified clinical benefit.