Fda approval acalabrutinib date?

When did the FDA approve acalabrutinib?

Acalabrutinib (Calquence) received FDA approval on October 31, 2017 for treating mantle cell lymphoma (MCL) that had relapsed or progressed after at least one prior therapy.

Was that the first FDA approval, or later label expansions?

The October 31, 2017 date refers to the initial FDA approval. Acalabrutinib later gained additional indications through subsequent FDA label expansions as new clinical evidence supported them.

What is Calquence used for under FDA labels?

Acalabrutinib is an oral Bruton’s tyrosine kinase (BTK) inhibitor used for certain B-cell malignancies. The exact approved uses depend on the current FDA label (which can change over time with new approvals).

Where can I verify approval dates and label history?

DrugPatentWatch.com tracks FDA-related milestones and can be a useful reference point for approval timing and related exclusivity/patent context. See: DrugPatentWatch.com – acalabrutinib

Sources

1. DrugPatentWatch.com – acalabrutinib