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Non-Hodgkin Lymphoma

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Related News

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 approves Bristol Myers Squibb’s Breyanzi for relapsed or refractory marginal zone lymphoma

May 18, 2026

The FDA approved Bristol Myers Squibb’s Breyanzi for adults with relapsed or refractory marginal zone lymphoma after at least two prior systemic therapies. In TRANSCEND FL, the CAR T therapy showed a 95.5% overall response rate and 62.1% complete response rate.

Calls grow to bring CAR-T cell therapy into New Zealand’s public health system

Apr 26, 2026

Calls are growing to bring CAR-T cell therapy to New Zealand as the current trial is set to end later this year. There is no clear path to public availability.

WHO targets child-friendly cancer drug formulations amid treatment gap

Apr 23, 2026

WHO in January 2024 launched its first list of priority childhood cancer drug formulations, naming six medicines that still lack optimal child-friendly versions. The agency says about 400,000 children and adolescents develop cancer each year and is working to expand access to safe, effective paediatric formulations.

Denileukin Diftitox Shows Promise Before CAR-T Therapy in High-Risk DLBCL

Mar 25, 2026

A phase 1 trial shows denileukin diftitox administered before CAR-T therapy has a favorable safety profile and encouraging efficacy in high-risk DLBCL patients, with an 86% overall response rate and 77% one-year progression-free survival. The treatment demonstrated consistent regulatory T-cell depletion, supporting its immunomodulatory mechanism. Larger controlled studies are needed to confirm these preliminary findings.

FDA Grants Fast Track Designation to Multiple Therapies for Rare Diseases and Hematologic Malignancies

Mar 11, 2026

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.

Three New Strategies Target Cancer Through Protein Regulation and Immune System Activation

Feb 25, 2026

Researchers report advances in cancer treatment through three distinct approaches: repurposing a heart medication to target lymphoma enzymes, blocking stress proteins to enhance immunotherapy, and developing antibodies that restore immune system attacks on tumors.

FDA Accepts Tirabrutinib Application for Relapsed Primary CNS Lymphoma

Feb 24, 2026

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.

FDA Accepts Tirabrutinib NDA for Relapsed/Refractory PCNSL, Sets December 2026 Action Date

Feb 18, 2026

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.

FDA Accepts Tirabrutinib NDA for Relapsed/Refractory PCNSL with December 2026 PDUFA Date

Feb 16, 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.

Related Clinical Trials

NCT ID	Title	Status	Phase
NCT07614035	Identification of the Best Treatment Pathway for Patients With Relapsed/Refractory Lymphocytic B-derived Non-Hodgkin Lymphoma	NOT_YET_RECRUITING
NCT07566377	Cord Blood Transplantation in Children and Young Adults With Blood Cancer	RECRUITING	PHASE2
NCT07456371	PIC1 Injection Therapy for Relapsed/Refractory B-NHL	RECRUITING	PHASE1
NCT07292272	Halt Aging in Survivors of Blood Cancers	RECRUITING	PHASE2
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NCT07283822	Amping up With PemJAK	RECRUITING	PHASE2
NCT07260812	KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma	RECRUITING	PHASE1
NCT07259304	Social Health, Activity Behaviors, and Quality of Life Among Young Adult Cancer Survivors	RECRUITING
NCT07254793	Prophylactic and Therapeutic DLI-X for Leukemia Relapse After HCT	NOT_YET_RECRUITING	PHASE1
NCT07249528	A Study of Voice as a Way to Monitor for Side Effects in People Receiving CAR T-Cell Therapy	RECRUITING