Joanna Sadowska, Director of Clinical Solutions at Biorce, shared on LinkedIn:
“Breaking News – FDA approves J&J’s dual-targeted cancer therapy after 42% response rate in head and neck cancer
Johnson & Johnson has received FDA accelerated approval for Rybrevant Faspro (subcutaneous amivantamab) for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
The approval is based on results from the Phase 1b/2 OrigAMI-4 trial in 102 patients whose cancer had progressed following chemotherapy and immunotherapy.
The results:
- 42% overall response rate.
- 15% of patients achieved a complete response.
- 56% of responders maintained their response for more than six months.
Rybrevant Faspro is a bispecific antibody that simultaneously targets EGFR and MET, two pathways involved in cancer growth and progression. This is the first approval for Rybrevant Faspro beyond lung cancer.
The approval is accelerated, and a Phase 3 trial is ongoing to confirm clinical benefit.
Hi! I am Joanna, and my friends call me Dr Jojo.
Planning a clinical trial or looking to improve trial design and execution?
DM me – I’d love to connect.”
You can also read:
After a Decade Without a New Option, FDA Approves Amivantamab for Head and Neck Cancer
