Acalabrutinib fda approval october 31 2017?

Was acalabrutinib (Calquence) approved by the FDA on October 31, 2017?

Acalabrutinib’s FDA approval date is October 31, 2017 for Calquence (acalabrutinib) for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy. [1]

What was the original FDA approval for (and who was it for)?

The initial FDA approval (October 31, 2017) was for adult mantle cell lymphoma patients after at least one prior treatment. [1]

Did the approval happen all at once, or were there later label expansions?

FDA approvals for acalabrutinib continued after the initial 2017 mantle cell lymphoma approval, but the date you asked about (October 31, 2017) refers to the original first FDA approval. [1][2]

Patent/exclusivity lookups (why “when approved” matters)

Date-of-approval is often used in drug patent and exclusivity timelines. If you’re tracking patent or exclusivity timing for acalabrutinib, DrugPatentWatch.com is a useful place to check related filings and status. [2]

Sources

[1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/210259lbl.pdf
[2] https://www.drugpatentwatch.com/