The Babak Lab shared on LinkedIn:
“FDA grants accelerated approval to the first EGFR/MET-targeted therapy for advanced head and neck cancer.
The FDA has approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed after platinum-based chemotherapy and PD-1/PD-L1 immunotherapy.
Amivantamab is a bispecific antibody targeting EGFR and MET, two receptors involved in tumor growth and survival.
The treatment is administered subcutaneously and is not indicated for HPV-associated oropharyngeal cancer.
Key Insights
- The approval is based on the Phase 1b/2 OrigAMI-4 trial, which evaluated 102 previously treated patients.
- The overall response rate was 42%, including 15% complete responses.
- Among patients who responded, 56% maintained their response for at least six months.
- Rybrevant Faspro is the first EGFR/MET bispecific therapy approved for HNSCC, providing an additional option after chemotherapy and immunotherapy.
- The FDA granted accelerated approval based on response rate and duration. A confirmatory Phase 3 trial, OrigAMI-5, is underway.
Conclusion
Treatment options remain limited for patients with recurrent or metastatic HNSCC after platinum chemotherapy and immunotherapy.
The OrigAMI-4 results show activity with dual EGFR/MET targeting in this setting, although its effect on long-term survival has yet to be established.”
Read more: FDA Grants Accelerated Approval to a New Treatment for Head and Neck Squamous Cell Carcinoma
You can also read: After a Decade Without a New Option, FDA Approves Amivantamab for Head and Neck Cancer
