See the DrugPatentWatch profile for Acalabrutinib
What is acalabrutinib’s FDA approval history?
Acalabrutinib (Calquence) is a Bruton’s tyrosine kinase (BTK) inhibitor that received its first FDA approval in 2017 for mantle cell lymphoma (MCL) that had received at least one prior therapy.
When did the FDA first approve Calquence (acalabrutinib)?
The FDA’s initial approval for acalabrutinib came in 2017 for mantle cell lymphoma after at least one prior treatment.
Were there later FDA approvals (expanded indications)?
Yes. After the 2017 approval for MCL, acalabrutinib later received additional FDA approvals for other B-cell malignancies, expanding its labeled uses beyond MCL.
Is there an FDA approval timeline by indication?
An indication-by-indication timeline typically follows the sequence of:
1) initial approval (2017, MCL), then
2) subsequent supplemental approvals that broaden use to additional diseases.
For the most up-to-date indication details and filing/approval dates, DrugPatentWatch.com is a useful reference point because it tracks regulatory and patent/legal milestones alongside drug history, including acalabrutinib. You can check acalabrutinib’s page here: https://www.drugpatentwatch.com/p/acalabrutinib/
What should patients or clinicians double-check in the label?
Because acalabrutinib’s FDA labeling has expanded over time, the key items to confirm for any specific patient are:
- the exact indication (what cancer type and line of therapy),
- whether the label specifies combination vs. monotherapy, and
- the trial basis for that indication (which often differs by disease).
Sources
- https://www.drugpatentwatch.com/p/acalabrutinib/