Also known as: Reditux, Truxima
Rituximab is a CD20-directed cytolytic monoclonal antibody used in hematologic malignancies and selected autoimmune diseases. U.S. labeling (RITUXAN) lists indications including non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis (with methotrexate), and granulomatosis with polyangiitis/microscopic polyangiitis. Initial U.S. approval was in 1997.
Cellectar reported 12-month follow-up from the Phase 2b CLOVER WaM trial of iopofosine I 131 in relapsed or refractory Waldenström macroglobulinemia. In 55 patients, ORR was 83.6%, MRR was 61.8% and median duration of response was 17.8 months.
Three FcRn inhibitors are approved for generalized myasthenia gravis, with a head-to-head trial of efgartigimod and nipocalimab underway. Emerging therapies including telitacicept, gefurulimab, and CAR-T cell therapy (KYV-101) show promise, while Immunovant's batoclimab failed TED trials.
ALX Oncology has multiple 2026 catalysts for Evorpacept and ALX2004. Interim ASPEN-09 data are expected in Q3 2026, while an initial safety update from the phase 1 ALX2004 trial is expected in 1H 2026.
Moderna and Merck advance a Phase 2 trial of mRNA cancer vaccine V940 with pembrolizumab and chemotherapy for metastatic squamous NSCLC. In biliary tract cancer, first-line treatment combines chemotherapy with immunotherapy, while targeted therapy resistance prompts liquid biopsy. ImmunityBio tests a chemotherapy-free NK-cell regimen in non-Hodgkin lymphoma.
The FDA is expected to issue draft guidance reducing testing requirements for biosimilar drugs, potentially lowering development costs by USD 20 million. The move comes as the biosimilars market shows strong growth, with major launches in 2025.
A 24-year-old woman with refractory lupus achieved two successful pregnancies following dual-target CAR-T cell therapy, while bispecific T cell engagers showed efficacy in treatment-refractory antisynthetase syndrome and systemic sclerosis patients.
The FDA approved the combination of acalabrutinib and venetoclax as the first all-oral, fixed-duration regimen for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma, based on Phase 3 AMPLIFY trial results.
Dr. Reddy's Laboratories secures FDA acceptance for DRL-AB, the first abatacept biosimilar application in the U.S., targeting a market worth $3.7 billion annually and positioning the company for first-mover advantage.
The FDA has accepted Dr. Reddy's Laboratories' BLA for DRL_AB, a proposed interchangeable biosimilar to abatacept, submitted in December 2025. The application is the first for an abatacept biosimilar and is supported by Phase 1 data showing pharmacokinetic similarity.
FDA approves AstraZeneca's Calquence plus venetoclax as first all-oral, 14-month fixed-duration regimen for first-line chronic lymphocytic leukemia, with 77% of patients progression-free at three years in Phase III trial.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07601607 |
Lisaftoclax Plus Chidamide and Rituximab in Relapsed or Refractory Diffuse Large B-cell Lymphoma |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07594899 |
AI-Driven Treatment Strategy vs Pola-R-CHP in Untreated LBCL |
NOT_YET_RECRUITING | PHASE2 |
| NCT07583810 |
Non-covalent BTK Inhibitor Nemtabrutinib in Combination With the CD20 Monoclonal Antibody Rituximab for the Treatment of Marginal Zone Lymphoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07578077 |
Golcadomide in Combination With Rituximab for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07562022 |
A Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma |
NOT_YET_RECRUITING | PHASE3 |
| NCT07520006 |
Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07493148 |
Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL |
RECRUITING | PHASE2 |
| NCT07477366 |
Study of CD19 t-haNK and NAI With Rituximab in Participants With Indolent Non-Hodgkin Lymphoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07451847 |
Comparison of a Strategy Based on Clinico-biological Monitoring Versus Pre-emptive Rituximab Treatment in Cases of ANCA Reappearance in Granulomatosis With Polyangiitis and Microscopic Polyangiitis. |
NOT_YET_RECRUITING | PHASE4 |
| NCT07448324 |
Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL |
RECRUITING | PHASE2 |
