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

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. ad-hoc-news.dead-hoc-news.dead-hoc-news.deOpen source ↗ 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. Genmab is entitled to royalty payments on the drug.

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. The company's shares gained 3.0% the previous day.

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. 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. ad-hoc-news.dead-hoc-news.dead-hoc-news.deOpen source ↗ They include the primary results of the Phase 3 study EPCORE DLBCL-4.

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.