PCNSL stands for primary central nervous system lymphoma, an aggressive extranodal non-Hodgkin lymphoma confined to the brain, spinal cord, leptomeninges, or eyes at diagnosis.
The FDA has granted fast track designation to QRX003 for Netherton Syndrome and IBI3003 for relapsed or refractory multiple myeloma, while also accepting regulatory applications for other therapies addressing serious conditions with unmet medical needs.
The FDA accepted a new drug application for tirabrutinib to treat relapsed or refractory primary central nervous system lymphoma, with a decision expected December 18, 2026. The application is supported by phase 2 trial data showing a 67% overall response rate.
The FDA approved acalabrutinib plus venetoclax as the first all-oral, fixed-duration BTK inhibitor regimen for CLL/SLL and cleared monthly dosing for amivantamab in EGFR-mutated NSCLC. Additional regulatory reviews are underway for PCNSL and breast cancer treatments.
The FDA has accepted a new drug application for tirabrutinib, a BTK inhibitor, for relapsed/refractory primary central nervous system lymphoma under the accelerated approval pathway. The regulatory agency set a PDUFA target action date of December 18, 2026.
The FDA has accepted for filing the New Drug Application for tirabrutinib under the accelerated approval pathway for relapsed or refractory primary central nervous system lymphoma, setting a PDUFA action date of December 18, 2026.
Researchers have developed modified CAR T cells that overcome prostaglandin E2 suppression in solid tumors and a selective therapy targeting IGHV4-34 that spares healthy immune cells, addressing key limitations in current treatments.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07350850 |
A Multicenter Two-Cohort Study of Methotrexate, Rituximab, Sintilimab and Pirtobrutinib for Treatment-Naive PCNSL vs. Real-World Investigator-Selected Treatment (Observational Cohort) |
RECRUITING | PHASE2 |
| NCT06914700 |
A Nomogram for Predicting the Diagnosis of Central Malignant Tumors Based on Preoperative Clinical Characteristics and Laboratory Indicators: |
COMPLETED | |
| NCT06554561 |
A Study of Pomadomide in Combination With Rituximab and Methotrexate for Newly-diagnosed Primary Central Nervous System Lymphoma |
RECRUITING | PHASE1/PHASE2 |
| NCT05896007 |
Zanubrutinib Combined With Rituximab and Chemotherapy for Newly-Diagnosed PCNSLBCL Patients Intolerant to HSCT |
RECRUITING | PHASE2 |
| NCT05782374 |
Real World Data on Ibrutinib Use in PCNSL Rel/Ref |
ACTIVE_NOT_RECRUITING | |
| NCT05167630 |
Prognosis Factors in Patients With Primary Central Nervous System Lymphoma |
UNKNOWN | |
| NCT05021770 |
Orelabrutinib in Combination With Thiotepa in Refractory and Relapsed Primary CNS Lymphoma |
UNKNOWN | PHASE1/PHASE2 |
| NCT04514393 |
Ibrutinib With Methotrexate and Temozolomide for Patients With Newly Diagnosed Primary CNS Lymphoma |
UNKNOWN | PHASE2 |
| NCT04481815 |
Rituximab Plus Methotrexate With or Without Lenalidomide in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma |
RECRUITING | PHASE2 |
| NCT04438044 |
A Study to Evaluate ICP-022 in Patients With R/R PCNSL and SCNSL |
UNKNOWN | PHASE2 |
