Reported Earlier, FDA Grants J&J Accelerated Approval For Rybrevant Faspro In Advanced Head And Neck Squamous Cell Carcinoma, Based On OrigAMI-4 Phase 1b/2 Trial Showing 42% Overall Response Rate
Benzinga Newsdesk 9 hours ago
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Accelerated approval based on data demonstrating clinically meaningful efficacy, including a 42 percent overall response rate (95 percent confidence interval, 32–52 percent)1First advancement in the second-line
- Accelerated approval based on data demonstrating clinically meaningful efficacy, including a 42 percent overall response rate (95 percent confidence interval, 32–52 percent)1
- First advancement in the second-line treatment setting for recurrent or metastatic head and neck cancer in a decade, bringing a new subcutaneous option to patients with significant unmet need2-3
- Extending its well-established, dual-targeted benefit beyond lung cancer, RYBREVANT FASPRO™ targets both EGFR and MET pathways – two key drivers of tumor progression in head and neck cancer2