Accelerated Approval for AstraZeneca’s Calquence

FDA has granted accelerated approval to AstraZeneca’s Calquence (acalabrutinib) for treating adults with mantle cell lymphoma who have received at least one prior therapy. The kinase inhibitor works by blocking an enzyme needed by the cancer to multiply and spread, according to an FDA release.

Approval was based on data from a single-arm trial involving 124 patients that were evaluated on whether they experienced complete or partial shrinkage of their tumors after treatment (overall response rate). “In the trial, 81% of patients had a complete or partial response (40% complete response, 41% partial response),” the agency says. “Serious side effects include bleeding (hemorrhage), infections and irregular heartbeat (atrial fibrillation). Additional cancers, known as second primary malignancies, have occurred in some patients taking Calquence.”