Methotrexate is a cytotoxic antimetabolite drug used across oncology and immune-mediated diseases in indication-specific dosing regimens, often once weekly in non-oncology uses. Labeling requires careful dose scheduling because medication errors can cause fatal toxicity. Initial U.S. approval dates to 1953.
The FDA approved Tregzi (Orca-T), a first-of-its-kind regulatory T cell-based immunotherapy, for adults with blood cancers undergoing matched donor stem cell transplants. Approval was based on the PRECISION-T trial, in which 78% of treated patients achieved chronic GVHD-free survival at one year versus 38.4% with standard transplant.
Three trials show ultra-low-dose checkpoint inhibitors retain efficacy with reduced toxicity and dramatically lower costs. DELII and Patil et al. trials tested low-dose nivolumab in solid tumors and HNSCC; NIVIPIT tested intratumoral low-dose ipilimumab in melanoma.
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.
Atopic dermatitis updates in 2026 included long-term upadacitinib safety, phase 3 amlitelimab and rademikibart data, and 5-year interim dupilumab results in children. A market report also listed multiple emerging therapies in late-stage development.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07764601 |
R-MA-PD-1 Versus R-MA in Treatment-naive Primary CNS Lymphoma |
NOT_YET_RECRUITING | NA |
| NCT07724457 |
Testing the Addition of a New Anti-Cancer Drug, Glofitamab to Usual Chemotherapy for Burkitt and Double Hit Lymphoma |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT07689630 |
Anti-CD25 Monoclonal Antibody for Prevention of Acute GVHD After Haploidentical HSCT |
RECRUITING | PHASE3 |
| NCT07643103 |
Immuno-Targeted Therapy Plus Low-Dose Chemotherapy for Newly Diagnosed Adult Ph-Negative B-ALL: A Prospective Umbrella Trial |
NOT_YET_RECRUITING | PHASE2 |
| NCT07643038 |
Treatment Strategy for Patients With RA-ILD |
NOT_YET_RECRUITING | PHASE4 |
| NCT07636564 |
Testing Blinatumomab With or Without Revumenib in Patients With B-cell Acute Lymphoblastic Leukemia With a Genetic Change Requiring More Treatment |
NOT_YET_RECRUITING | PHASE2 |
| NCT07627893 |
Complementary Herbal Approach to Rheumatoid Management Study (CHARMS) |
RECRUITING | PHASE2/PHASE3 |
| NCT07581418 |
Comparison of Methotrexate and Tofacitinib in Chronic Plaque Psoriasis |
NOT_YET_RECRUITING | NA |
| NCT07543640 |
EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL. |
NOT_YET_RECRUITING | PHASE2 |
| NCT07498465 |
A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Mixed Phenotype Acute Leukemia |
WITHDRAWN | PHASE1 |
