Calquence is the brand name for acalabrutinib, a second-generation Bruton's tyrosine kinase inhibitor used in B-cell malignancies including CLL/SLL and mantle cell lymphoma. It is an oral targeted anti-cancer therapy with U.S. approvals and later traditional-approval updates. The medicine is prescription-only.
Several drugmakers saw shares fall after earnings missed expectations. Alnylam's Amvuttra sales disappointed despite growth; Neurocrine's guidance underwhelmed; AbbVie's Imbruvica and Roche's Vabysmo fell short of consensus.
AstraZeneca reported strong Q1 2026 results with 8% revenue growth and 12% operating profit growth, driven by its oncology portfolio and pipeline progress. The company also saw unusual options activity and maintained full-year guidance. Key oncology brands including Imfinzi and Enhertu showed double-digit growth.
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.
FDA approves Genentech's Tecentriq as first ctDNA-guided adjuvant therapy for muscle-invasive bladder cancer, and Venclexta plus acalabrutinib as first all-oral fixed-duration regimen for CLL.
The phase 3 AMPLIFY trial in frontline chronic lymphocytic leukemia showed improved efficacy with acalabrutinib plus venetoclax versus standard of care. The source text identified the study as NCT03836261.
Recent studies demonstrate zanubrutinib delivers higher response rates, longer treatment persistence, and lower healthcare costs compared to acalabrutinib and ibrutinib across multiple B-cell malignancies, with particularly strong benefits in high-risk populations.
AstraZeneca's CALQUENCE received FDA approval as the first all-oral, fixed-duration regimen for chronic lymphocytic leukemia, while the EMA validated the marketing authorization application for ENHERTU in HER2-positive breast cancer treatment.
The FDA approved acalabrutinib combined with venetoclax for chronic lymphocytic leukemia and small lymphocytic leukemia based on phase III trial results. Separately, Yale researchers identified CD25 protein complex as a new drug target for aggressive leukemias.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT05517265 |
Acalabrutinib in Patients With Chronic Lymphocytic Leukemia With Direct Oral Anticoagulation (CICERO) |
COMPLETED |
