Rybrevant Faspro (amivantamab SC) PDUFA Date (Johnson & Johnson)
FDA PDUFA decision date for Rybrevant Faspro (amivantamab SC) is February 17, 2026. Developed by Johnson & Johnson. Indication: EGFR-mutated non-small cell lung cancer (SC formulation). Current status: Approved.
Indication
EGFR-mutated non-small cell lung cancer (SC formulation)
Regulatory details
- Company: Johnson & Johnson
- Therapeutic area: Oncology
- Application type: sBLA
- Review type: Breakthrough
- PDUFA date: 2026-02-17
- Outcome: Approved