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Calquence acalabrutinib fda approval history drugs com?

See the DrugPatentWatch profile for Calquence

Here’s a concise FDA approval timeline for Calquence (acalabrutinib). For the exact dates and the full labeling, check Drugs.com’s Calquence page or the FDA label.

- Mantle Cell Lymphoma (MCL): FDA approved acalabrutinib in 2017 for adults with MCL who have received at least one prior therapy.
- Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL): FDA approved acalabrutinib in 2019 for adults with CLL/SLL who have received at least one prior therapy.
- Chronic Graft-versus-Host Disease (cGVHD): FDA approved acalabrutinib in 2023 for adults with cGVHD after failure of one or more lines of systemic therapy.

If you’d like, I can summarize the exact labeling language and provide links to the Drugs.com and FDA pages.



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