Back

FDA Grants Rybrevant Faspro Accelerated Head And Neck Cancer Approval

lite News Desk 2 min read

Rybrevant Faspro received accelerated U.S. approval on November 5, 2026, for use alone in certain adults with head and neck squamous cell carcinoma, according to the Food and Drug Administration. The indication covers recurrent or metastatic disease that progressed during or after treatment with both platinum-based chemotherapy and an anti-PD-(L)1 antibody.

According to the FDA notice, patients whose oropharyngeal squamous cell carcinoma is HPV-associated are outside the approved indication. The agency said p16 testing was used to exclude those patients from the pivotal trial.

Johnson & Johnson said Rybrevant Faspro combines amivantamab with hyaluronidase-lpuj in a formulation administered under the skin. The company identifies EGFR and MET as the two pathways targeted by amivantamab.

The FDA said its decision relied on OrigAMI-4, a trial conducted across multiple centers with an open-label design. The main group used to assess efficacy comprised 102 patients who had already received treatment. Participants received the drug alone through an injection under the skin once every three weeks, with treatment continuing until their cancer progressed or toxicity became unacceptable.

According to the agency, 42% of that group had a response, meaning their tumors became smaller or disappeared. The 95% confidence interval ranged from 32% to 52%. Responses were assessed through a blinded independent central review using RECIST v1.1 criteria. Among participants who responded, the response lasted six months or longer for 56%.

The FDA put the response rate for other currently approved treatments in this setting at approximately 20% or below. That comparison did not come from a trial testing those therapies directly against Rybrevant Faspro.

The agency said the accelerated decision was based on how often patients responded and how long those responses lasted. Whether these measures correspond to clinically meaningful outcomes over the longer term remains unestablished, according to the FDA, which requires confirmatory studies.

Johnson & Johnson said confirmation of clinical benefit through the ongoing Phase 3 OrigAMI-5 trial may be a condition of continued approval. In the company’s description, that study evaluates subcutaneous amivantamab alongside carboplatin and pembrolizumab as an initial treatment for head and neck cancer that is recurrent or metastatic.

The FDA’s safety notice includes precautions and warnings concerning eye toxicity, skin reactions, interstitial lung disease or pneumonitis, and embryo-fetal toxicity. It also covers hypersensitivity and reactions associated with administration.

* This article is based on publicly available information at the time of writing.

More from Health & Biotech

  1. According to the study, medium-HDI countries had the largest estimated increase, at 61,863 additional heat-related deaths per year.

  2. Rhythm says the portfolio royalty will be 1% of worldwide net sales from January 2029, or earlier if bivamelagon launches commercially.

  3. The tentative status permits U.S. government procurement during the original product’s patent-protection period, but not U.S. commercial sales.

  4. FDA recommends combining manufacturing controls and testing throughout development and production, rather than relying on lot-release assays alone.

  5. The approval covers adults with active psoriatic arthritis; ILUMYA injections must be administered by a healthcare provider.