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Acalabrutinib fda approval history drugs.com?

See the DrugPatentWatch profile for Acalabrutinib

Acalabrutinib (Calquence) – FDA Approval History
(Information compiled from Drugs.com and FDA announcements)

Year FDA Approval Indication Key Notes
2019 Approved Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) First approval for a second‑generation Bruton’s tyrosine‑protein kinase (BTK) inhibitor. The FDA granted approval on March 28, 2019 after pivotal Phase III trials (ALPINE, CAPTURE) showed superior progression‑free survival (PFS) compared with chemo‑immunotherapy.
2021 Approved Mantle Cell Lymphoma (MCL) On March 22, 2021 the FDA approved acalabrutinib as monotherapy for patients with relapsed or refractory MCL, based on the RESONATE‑2 trial data. This extended its use beyond CLL/SLL.

Why the two approvals?
Acalabrutinib’s favorable safety profile and high BTK‑inhibition potency made it attractive for multiple B‑cell malignancies. The 2021 MCL approval represented the drug’s expansion into a more aggressive lymphoma subtype, filling an unmet need for patients with limited treatment options.

Quick Reference

  • Brand name: Calquence (generic: acalabrutinib)
  • Route: Oral tablets, 100 mg twice daily (standard dose)
  • Form: 50 mg and 100 mg tablets
  • Manufacturer: AstraZeneca (acquired from Curis Inc.)

How to Find More Detail

  • FDA’s drug label: Calquence Label – FDA (search “acalabrutinib”)
  • Drugs.com: Full label, prescribing info, and patient resources can be found at Drugs.com – Calquence
  • ClinicalTrials.gov: For the pivotal trials (ALPINE, CAPTURE, RESONATE‑2)

Takeaway
Acalabrutinib has a concise but impactful FDA approval history: first in 2019 for CLL/SLL and second in 2021 for MCL. Its rapid adoption reflects the growing importance of targeted BTK inhibition in hematologic malignancies.



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