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Acalabrutinib shows efficacy as monotherapy in untreated CLL
Key clinical point: Acalabrutinib, which has shown efficacy in relapsed CLL, has now shown efficacy as a monotherapy for patients with previously...
The Food and Drug Administration has granted accelerated approval to acalabrutinib, a Bruton tyrosine kinase inhibitor, for the treatment of adults with mantle cell lymphoma (MCL) who have received at least one prior therapy.
Approval was based on an 81% overall response rate in a phase 2, single-arm trial (ACE-LY-004) of 124 patients with MCL who had received at least one prior treatment (40% complete response, 41% partial response), the FDA said in a statement.
Serious adverse effects include hemorrhage and atrial fibrillation. Second primary malignancies have occurred in some patients, according to the FDA.
Acalabrutinib will be marketed as Calquence by AstraZeneca. The company is currently enrolling patients in a phase 3 trial evaluating acalabrutinib as a first-line treatment for patients with MCL in combination with bendamustine and rituximab.
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