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FDA Accepts Deciphera's NDA for Tirabrutinib in Relapsed/Refractory PCNSL

Jun 15, 2026

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.

FDA Accepts NDA for Tirabrutinib in Relapsed/Refractory Primary CNS Lymphoma

Jun 01, 2026

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.

Phase III frontMIND Trial Shows Tafasitamab-Lenalidomide-R-CHOP Boosts PFS in High-Risk B-Cell Lymphomas

May 30, 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.

Tempest Therapeutics Reports 2025 Financial Results and Clinical Progress

Mar 30, 2026

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.

FDA Approves CAR-T Therapy for Marginal Zone Lymphoma, New Myeloma Drug Advances to Phase 2

Mar 24, 2026

The FDA has approved Bristol Myers Squibb's CAR-T therapy Breyanzi for relapsed/refractory marginal zone lymphoma, while a novel multiple myeloma drug candidate DTP3 advances to Phase 2 trials after showing promising early results. Both developments represent significant progress in blood cancer treatment, with the marginal zone lymphoma approval based on a 95.5% response rate and the myeloma drug demonstrating selective cancer cell killing without toxicity.