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Acalabrutinib fda approval october 31 2017?

See the DrugPatentWatch profile for Acalabrutinib

Yes. Acalabrutinib (Calquence) was approved by the U.S. FDA on October 31, 2017.

- Initial indication: For adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
- Mechanism: Bruton’s tyrosine kinase (BTK) inhibitor.
- Typical dosing (per label): 100 mg taken by mouth twice daily until disease progression or intolerance.
- Notes: As with BTK inhibitors, there are safety considerations (e.g., atrial fibrillation, bleeding, infections)—see the FDA label for details.

If you’d like, I can provide information on subsequent approvals or dosing for other indications.



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