Fludarabine is a purine analogue antineoplastic chemotherapy agent used for leukemia and lymphoma, including chronic lymphocytic leukemia. It is commonly administered as fludarabine phosphate by intravenous or oral routes. It was approved for medical use in the United States in 1991.
Soft tissue sarcoma pipeline activity includes 70+ companies and 75+ therapies. A phase II ADI-PEG 20 trial with gemcitabine and docetaxel was designed for sarcomas, while other 2026 studies span synovial sarcoma and unresectable advanced disease.
The multiple myeloma treatment landscape is rapidly expanding with over 75 companies developing 80+ pipeline therapies, while clinicians navigate evolving questions about transplant timing, quadruplet regimens, and minimal residual disease testing in newly diagnosed patients.
New CAR T-cell approaches targeting BCMA and CD19 simultaneously show encouraging early results, while researchers develop control strategies for CAR-T therapies including antibody-drug conjugates.
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.
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.
The FDA has approved the combination of acalabrutinib and venetoclax as the first all-oral, fixed-duration BTK inhibitor-based regimen for previously untreated adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.
The FDA has approved a supplemental new drug application for the combination regimen of Venclexta (venetoclax) and acalabrutinib for previously untreated adult patients with chronic lymphocytic leukemia, supported by Phase 3 AMPLIFY trial data.
The FDA approved acalabrutinib plus venetoclax as the first all-oral, fixed-duration regimen for previously untreated chronic lymphocytic leukemia, based on phase III AMPLIFY trial results showing 35% reduction in disease progression or death risk versus chemoimmunotherapy.
The FDA approved 46 novel drugs in 2025, down from 50 in 2024. Small molecules accounted for 31 approvals (67%), with oncology leading at nine approvals. Large molecules contributed 15 approvals (33%), spanning ADCs, bispecifics, and subcutaneous delivery innovations.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07604233 |
Phase 1/2 FLAG-IDA, VEN and Asciminib in CML and Ph+ AML |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07598955 |
Target-Selected CAR-NK Cells (CD30, CD5, or Mesothelin) for Relapsed/Refractory B2 Thymoma or Thymic Carcinoma |
RECRUITING | PHASE1/PHASE2 |
| NCT07593482 |
Bendamustine Versus Fludarabine/Cyclophosphamide for Lymphodepletion in Chimeric Antigen Receptor T-cell Immunotherapy (CAR-T): a Randomized Trial. |
NOT_YET_RECRUITING | PHASE2 |
| NCT07591649 |
Adapt NK for High Risk Myeloid Diseases as Bridge to Allo HSCT |
RECRUITING | PHASE1/PHASE2 |
| NCT07589543 |
Dual-Target CAR-NK Cells in Recurrent or Refractory Epithelial Ovarian Cancer |
RECRUITING | PHASE1/PHASE2 |
| NCT07589530 |
Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors |
RECRUITING | PHASE1/PHASE2 |
| NCT07583303 |
BSB-2002 After Cyclophosphamide and Fludarabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation |
NOT_YET_RECRUITING | PHASE1 |
| NCT07575893 |
CD30 CAR-T Cells for Low Risk Relapsed Classical Hodgkin Lymphoma |
NOT_YET_RECRUITING | PHASE1 |
| NCT07573332 |
A Safety and Tolerability Study of CC- 97540 (BMS-086353) in Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Patients |
NOT_YET_RECRUITING | PHASE1 |
| NCT07572136 |
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL) |
NOT_YET_RECRUITING | PHASE1 |
