FDA grants accelerated approval to Johnson & Johnson’s Rybrevant Faspro for advanced head‑and‑neck cancer
+1 new source since this summary was written
The U.S. Food and Drug Administration granted accelerated approval to Johnson & Johnson’s sub‑cutaneous Rybrevant Faspro (amivantamab and hyaluronidase‑lpuj) for adults with recurrent or metastatic head‑and‑neck squamous cell carcinoma who have progressed after platinum‑based chemotherapy and an anti‑PD‑(L)1 therapy. The approval is based on the phase 1b/2 OrigAMI‑4 trial, which showed a confirmed overall response rate of 42 % (95 % CI 32‑52 %). Continued approval will depend on clinical benefit confirmation in the ongoing phase 3 OrigAMI‑5 study.
Why it matters
The approval adds the first dual‑targeted EGFR/MET therapy for this indication, expanding Johnson & Johnson’s oncology portfolio and creating a new revenue stream. However, the label is contingent on positive results from the confirmatory trial, so future sales depend on that outcome.
Key facts
- 1The FDA granted accelerated approval on November 5, 2026. targetedonc.com
- 2The indication excludes patients with HPV‑associated oropharyngeal squamous cell carcinoma as determined by p16 immunohistochemistry. targetedonc.com
- 3The pivotal OrigAMI‑4 trial enrolled 102 patients. targetedonc.com
- 4Confirmed overall response rate was 42 % (95 % CI 32‑52 %). targetedonc.com
- 5Complete responses occurred in 15 % of patients and partial responses in 28 %. targetedonc.com
- 6Continued approval may be contingent on the phase 3 OrigAMI‑5 confirmatory trial. targetedonc.com
Summary written by AlphAI AI Desk from 11 of 11 sources. Not investment advice. Figures are as stated by the linked sources.