The U.S. FDA has accepted for filing a 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. The submission is supported by Phase 2 PROSPECT study results showing a 67% overall response rate and 44% complete response rate. If approved, tirabrutinib would be the first BTK inhibitor commercially available in the U.S. for this indication.
Real-world studies show early complete response after CAR T-cell therapy predicts sustained remission in large B-cell lymphoma, while historical chemotherapy yields poor outcomes in high-risk patients. Data from registries highlight a significant event-free survival advantage for second-line axicabtagene ciloleucel versus standard-of-care salvage therapy.
The FDA has accepted for review a New Drug Application for tirabrutinib, a Bruton tyrosine kinase inhibitor, for relapsed or refractory primary central nervous system lymphoma. The application is based on phase 2 PROSPECT trial data showing an overall response rate of 67% and complete response rate of 44%. The target action date is December 18, 2026.
The phase III frontMIND trial showed that adding tafasitamab and lenalidomide to R-CHOP chemotherapy reduced the risk of progression by 25% in patients with high-risk B-cell lymphomas. The 3-year progression-free survival was 67.3% with the combination versus 60.7% with R-CHOP alone. A dual-targeted CD19/CD20 immunotherapy regimen has also been approved in Australia for relapsed follicular lymphoma.
BMS's mezigdomide doubled progression-free survival in relapsed/refractory multiple myeloma at ASCO, while the FDA reviews iberdomide with a decision due by August 17. C4 Therapeutics has dosed the first patient in its Phase 2 MOMENTUM trial of cemsidomide.
The FDA approved oral decitabine and cedazuridine tablets plus venetoclax for newly diagnosed AML in patients 75 and older or those ineligible for intensive induction chemotherapy. The approval was supported by phase 1/2 ASTX727-07 data showing a 41.6% complete response rate.
Cynata raised $1.5 million through a placement at $0.25 a share ahead of Phase 3 osteoarthritis and Phase 2 aGvHD trial readouts due in May and June 2026. Its aGvHD study has completed the 100-day primary evaluation period for all 65 participants.
The 2026 Tandem Meetings featured new data on CAR-T, allogeneic transplantation, and supportive care. Highlights included early efficacy signals for EB-103, KITE-753, Orca-T, and NXC-201, plus comparative cardiovascular safety data for lisocabtagene maraleucel.
Tempest Therapeutics reported 2025 financial results showing $7.7 million in cash and highlighted clinical progress including 100% complete response rate in TPST-2003 CAR-T trial and multiple FDA designations for amezalpat in hepatocellular carcinoma. The company completed strategic CAR-T asset acquisition and plans Phase 2b registrational study for its lead program in 2026.
The phase 3 ENVISION trial shows 80% complete response rate for novel bladder cancer chemoablative therapy. AI integration accelerates precision oncology through biomarker identification and targeted treatments. OncoPRO real-time symptom monitoring system enhances patient safety and clinical trial data capture.
