# FDA grants accelerated approval to Rybrevant Faspro for recurrent head and neck squamous cell carcinoma

- Published: 2026-11-10 13:50 UTC
- Section: Life & Health › Medicine
- Tags: Rybrevant Faspro, FDA accelerated approval, head and neck squamous cell carcinoma, Genmab revenue 2026, Genmab guidance, epcoritamab ASH, EPCORE DLBCL-4, Johnson & Johnson
- URL: https://realtech.media/news/rt-d278e0349d82c94ddab09154_fda_grants_accelerated/

**The US FDA approved Rybrevant Faspro for adults whose head and neck cancer progressed after platinum chemotherapy and an anti-PD-(L)1 antibody. Genmab is entitled to royalties.**

![FDA grants accelerated approval to Rybrevant Faspro for recurrent head and neck squamous cell carcinoma](https://realtech.media/media/2026/11/98ba1341d6786bdb.webp)
*ad-hoc-news.de*

The US Food and Drug Administration (FDA) granted accelerated approval to Rybrevant Faspro on Thursday for adults with recurrent or metastatic squamous cell carcinoma of the head and neck, ad-hoc-news.de reports. [1] According to Johnson & Johnson, the approval covers patients whose disease progressed during or after platinum-based chemotherapy and treatment with an anti-PD-(L)1 antibody. [1] Genmab is entitled to royalty payments on the drug. [1]

## Genmab revenue and guidance

On Thursday Genmab also reported revenue of $3.24 billion for the first nine months of 2026. That is 22% more than in the same period a year earlier. [1] The company's shares gained 3.0% the previous day. [1]

In its mandatory disclosure, Genmab confirmed its full-year 2026 revenue guidance. The expected range remains $4,325–4,525 million, and the company expects a result at the upper end of it. [1] The limits of the guidance were not raised; the confirmation was combined with an assessment of where within the range annual revenue is likely to fall.

## Epcoritamab at the ASH meeting

Also on Thursday, Genmab announced its contributions on epcoritamab for the ASH meeting. In total, 22 abstracts are to be presented or published there. [1] They include the primary results of the Phase 3 study EPCORE DLBCL-4. [1]

The announcement refers to both presentations and publications at the meeting; Genmab did not announce a talk for every contribution. The ASH meeting is scheduled for 12–15 December 2026. This sets a concrete future framework for presenting or publishing the announced epcoritamab contributions.

## Sources

1. [ad-hoc-news.de](https://www.ad-hoc-news.de/boerse/news/unternehmensnachrichten/genmab-aktie-fda-zulassung-fuer-rybrevant-faspro/70484077)

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Source: RealTech, realtech.media — https://realtech.media/news/rt-d278e0349d82c94ddab09154_fda_grants_accelerated/