FDA Grants Accelerated Approval to Acalabrutinib for Mantle Cell Lymphoma

The U.S. Food and Drug Administration (FDA) granted accelerated approval to acalabrutinib, a second-generation Bruton tyrosine kinase, as secondline treatment for patients with mantle cell lymphoma.

The approval is supported by a study of 124 patients who had received at least one prior treatment. After taking acalabrutinib, 40 percent went into remission and another 41 percent saw their tumors shrink. Serious adverse events included bleeding, infections, and irregular heartbeat; some study participants developed a second malignancy.

The study did not include a comparison group.

Source: AstraZeneca press release, October 31, 2017.