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Calquence FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 8, 2022.

FDA Approved: Yes (First approved October 31, 2017)
Brand name: Calquence
Generic name: acalabrutinib
Dosage form: Capsules and Tablets
Company: AstraZeneca
Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia

Calquence (acalabrutinib) is a highly selective, potent, Bruton tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma (MCL), and chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma.

Development timeline for Calquence

Aug  5, 2022Approval Calquence Tablet Formulation Approved in the US Across Current indications
Nov 12, 2020Update on CALAVI Phase II Trials for Calquence in Patients Hospitalised with Respiratory Symptoms of COVID-19
Jun  5, 2020Calquence Showed Promising Clinical Improvement in Majority of 19 Hospitalised COVID-19 Patients
Apr 14, 2020AstraZeneca Initiates CALAVI Clinical Trial with Calquence Against COVID-19
Nov 21, 2019Approval FDA Approves Calquence for Adults with Chronic Lymphocytic Leukemia
Oct 31, 2017Approval FDA Approves Calquence (acalabrutinib) for Adults with Mantle Cell Lymphoma
Aug  2, 2017US FDA Accepts Regulatory Submission for Acalabrutinib and Grants Priority Review
Aug  1, 2017Acalabrutinib Granted Breakthrough Therapy Designation by US FDA for the Treatment of Patients with Mantle Cell Lymphoma

Further information

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