Tirabrutinib PDUFA Date (Deciphera Pharmaceuticals)
FDA PDUFA decision date for Tirabrutinib is December 18, 2026. Developed by Deciphera Pharmaceuticals. Indication: Relapsed/refractory primary CNS lymphoma (PCNSL). Current status: Near-Term.
Indication
Relapsed/refractory primary CNS lymphoma (PCNSL)
Notes
Orphan drug designation. No approved therapies for PCNSL.
Regulatory details
- Company: Deciphera Pharmaceuticals
- Therapeutic area: Oncology / CNS
- Application type: NDA
- Review type: Priority
- PDUFA date: 2026-12-18
- Outcome: Pending