The Priority Review

Approvals Brief

Johnson & Johnson FDA grants accelerated approval for RYBREVANT FASPRO in head and neck cancer

The FDA granted accelerated approval for RYBREVANT FASPRO as a single agent for adults with recurrent or metastatic head and neck squamous cell carcinoma that progressed after platinum-based chemotherapy and an anti-PD-(L)1 antibody. The approval was based on the Phase 1b/2 OrigAMI-4 trial, in which the confirmed overall response rate was 42 percent per blinded independent central review.

Primary source

Company press release (PR Newswire), November 9, 2026

Raised Outlooks and a Cancer Approval Arrive in the Middle of Medicare Open Enrollment

Read the source: Raised Outlooks and a Cancer Approval Arrive in the Middle of Medicare Open Enrollment prnewswire.com

Machine-summarized from the source above; not independently reported. How we use automation