The FDA grants Calquence® (acalabrutinib) accelerated approval for the treatment of R/R MCL

On 31^st October 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Calquence® (acalabrutinib) for the treatment of adult mantle cell lymphoma (MCL) patients who have previously received at least one therapy. The accelerated approval for AstraZeneca’s Bruton’s tyrosine kinase (BTK) inhibitor follows prior granting of Breakthrough Therapy Designation, and Priority Review in August 2017.

This approval was based on data from the ACE-LY-004 trial (NCT02213926). This is a phase II, open-label study aiming to determine the safety and efficacy of Calquence® (acalabrutinib) in patients with relapsed/refractory (R/R) MCL. Reported key investigator assessed efficacy results from 124 patients recruited to the ACE-LY-004 trial included an overall response rate of 81% (95% CI: 73–87), and a complete response rate of 40% (95% CI: 31–49), with a median follow-up of 15.2 months.

The full indication and usage from the prescribing information is as follows:

CALQUENCE is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials

These results from the ACE-LY-004 trial are the first MCL data announced from AstraZeneca’s Calquence® (acalabrutinib) development program investigating monotherapy and combination regimens in a wide range of solid and hematological tumors. One such ongoing phase III trial (ACE-LY-308) is evaluating the potential of front-line Calquence® (acalabrutinib) in combination with rituximab and bendamustine in the treatment of MCL (NCT02972840). Additional studies are also ongoing including a phase II study of acalabrutinib in R/R Chronic Lymphocytic Leukemia (CLL) and newly diagnosed del(17p) CLL (NCT02337829), and a broader phase I/II trial of acalabrutinib combined with the PI3K inhibitor ACP-319 in B-cell malignancies (NCT02328014).