The Food and Drug Administration (FDA) has approved Calquence (acalabrutinib; AstraZeneca) for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The approval was based on data from 2 randomized, controlled trials (ELEVATE-TN and ASCEND). In ELEVATE-TN, 535 patients with previously untreated CLL were randomized to receive Calquence monotherapy, Calquence in combination with obinutuzumab, or obinutuzumab in combination with chlorambucil. The primary end point of the study was progression-free survival (PFS). Results showed that patients who received Calquence had a longer PFS compared with those who received obinutuzumab plus chlorambucil. In the Calquence combination arm, risk of disease progression or death was reduced by 90% (hazard ratio [HR] 0.10; 95% CI, 0.06-0.17, P <.0001) and in the monotherapy arm it was reduced by 80% (HR 0.20; 95% CI, 0.13-0.30, P <.0001).
In ASCEND, 310 patients with relapsed or refractory CLL after at least 1 prior systemic therapy were randomized to receive Calquence, idelalisib plus a rituximab product, or bendamustine plus a rituximab product. In this trial, treatment with Calquence resulted in longer PFS compared with the other standard treatments (HR 0.31; 95% CI: 0.20, 0.49; P <.0001).
“As part of a US, Australian and Canadian collaboration known as Project Orbis, the US approved a new treatment option for those living with chronic lymphocytic leukemia or small lymphocytic lymphoma,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.”The FDA’s Project Orbis provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international partners.”
Calquence, an inhibitor of Bruton tyrosine kinase, is also indicated for the treatment of mantle cell lymphoma in patients who have received at least 1 prior therapy. It is supplied as 100mg capsules.
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