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Calquence Approval History

FDA Approved: Yes (First approved October 31, 2017)
Brand name: Calquence
Generic name: acalabrutinib
Dosage form: Capsules
Company: AstraZeneca
Treatment for: Mantle Cell Lymphoma

Calquence (acalabrutinib) is a highly selective, potent, Bruton tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma (MCL).

Development History and FDA Approval Process for Calquence

Oct 31, 2017Approval FDA Approves Calquence (acalabrutinib) for Adults with Mantle Cell Lymphoma
Aug  2, 2017US FDA Accepts Regulatory Submission for Acalabrutinib and Grants Priority Review
Aug  1, 2017Acalabrutinib Granted Breakthrough Therapy Designation by US FDA for the Treatment of Patients with Mantle Cell Lymphoma

Further information

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