US FDA approved Calquence (acalabrutinib) plus venetoclax as the first all-oral, fixed-duration regimen for adults with chronic lymphocytic leukaemia and small lymphocytic lymphoma. Approval based on AMPLIFY phase III trial showing 77% progression-free at three years vs 67% with chemoimmunotherapy. Regimen already cleared in EU, UK, and Canada.
New market reports forecast significant expansion in CAR T-cell therapy, US pharmaceutical drug delivery, and healthcare nanotechnology sectors, driven by chronic disease prevalence and technological advances.
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.
The FDA approved acalabrutinib plus venetoclax as the first all-oral, fixed-duration BTK inhibitor regimen for CLL/SLL and cleared monthly dosing for amivantamab in EGFR-mutated NSCLC. Additional regulatory reviews are underway for PCNSL and breast cancer treatments.
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 has approved the combination of Venclexta (venetoclax) plus acalabrutinib as the first all-oral, fixed-duration regimen for previously untreated adults with chronic lymphocytic leukemia, based on Phase III AMPLIFY study results.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07342478 |
ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL |
RECRUITING | PHASE3 |
| NCT07120633 |
Anti CD19 CAR-T Combined With BTKi to Treat Newly Diagnosed High-risk CLL/SLL |
RECRUITING | NA |
| NCT07108998 |
Study of Epcoritamab as a Consolidation Therapy in CLL/SLL |
RECRUITING | PHASE2 |
| NCT05947851 |
A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010). |
RECRUITING | PHASE3 |
| NCT04806035 |
Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia |
TERMINATED | PHASE1 |
| NCT04704323 |
CAP-100 for Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia |
RECRUITING | PHASE1 |
| NCT04694560 |
A Time-Limited Approach to Treatment With Ibrutinib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma |
WITHDRAWN | |
| NCT03639324 |
Rituximab, Idelalisib, and Venetoclax in Relapsed/Refractory CLL/SLL |
WITHDRAWN | PHASE1 |
| NCT03572634 |
Phase 1/2 Study of TP-0903 (an Inhibitor of AXL Kinase) in Patients With Previously Treated CLL |
TERMINATED | PHASE1/PHASE2 |
| NCT02863692 |
Registry of the German CLL Study Group |
RECRUITING |
