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Acalabrutinib fda approval october 31 2017 calquence?

See the DrugPatentWatch profile for Acalabrutinib

Acalabrutinib (Calquence®) – FDA Approval (October 31 , 2017)

Item Details
Drug Acalabrutinib – a second‑generation, reversible Bruton’s tyrosine‑kinase (BTK) inhibitor
Brand name Calquence®
FDA approval date 31 Oct 2017
Approved indications 1. Chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) – when combined with anti‑CD20 monoclonal antibodies (rituximab or obinutuzumab).
2. Mantle cell lymphoma (MCL) – as a monotherapy for patients who have received at least one prior therapy.
Key clinical trials • ASCEND (CLL/SLL): Randomized, phase‑3 study showing improved progression‑free survival (PFS) when acalabrutinib + obinutuzumab or rituximab versus chlorambucil + rituximab.
• ASCEND‑MCL (MCL): Phase‑3 study demonstrating durable responses in relapsed/refractory MCL patients.
Mechanism of action Binds irreversibly (via a covalent bond) to cysteine-481 in BTK, thereby inhibiting BTK signaling that promotes B‑cell proliferation and survival. Its design yields improved selectivity over ibrutinib, reducing off‑target effects (e.g., less atrial fibrillation or bleeding).
Common adverse events • Bleeding (mild), • Headache, • Upper respiratory tract infections, • Diarrhea, • Anemia (rare)
Key differences from ibrutinib • Greater selectivity → fewer cardiac events.
• Lower incidence of atrial fibrillation.
• Better tolerability in many patients.
Post‑approval updates • 2020: FDA expanded approval for relapsed/refractory CLL/SLL and MCL (combination with anti‑CD20 antibodies).
• 2022: Additional indication for Waldenström macroglobulinemia (WM) (under accelerated approval).

Quick Take‑away

  • FDA approved Calquence on Oct 31 2017 for CLL/SLL (with anti‑CD20) and MCL (monotherapy).
  • It’s a BTK inhibitor designed to be more selective and better tolerated than earlier agents like ibrutinib.
  • Since approval, Calquence has become a mainstay in the treatment of several B‑cell malignancies, especially in patients who cannot tolerate the side‑effect profile of first‑generation BTK inhibitors.

Feel free to ask if you’d like more details on dosing, safety monitoring, or how it fits into current treatment algorithms!



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