FDA Grants Accelerated Approval to AstraZeneca’s Calquence
The FDA granted accelerated approval to AstraZeneca’s Calquence (acalabrutinib) for mantle cell lymphoma patients that have received at least one prior therapy. Calquence blocks an enzyme that helps the cancer multiply and spread.
The approval was based on a single-arm trial of 124 patients, measuring the rate of shrinkage of tumors after treatment — 40 percent of patients demonstrated complete response, while 41 percent showed a partial response.
According to the FDA, AstraZeneca is currently conducting its larger follow-up trial to establish clinical benefit, as required under accelerated approval. The agency had granted the application priority review and breakthrough therapy designations, as well as an orphan drug designation.