Regulatory Affairs

AstraZeneca’s Calquence secures FDA approval for mantle cell lymphoma

PBR Staff Writer Published 01 November 2017

AstraZeneca’s Calquence (acalabrutinib) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.

MCL represents 3% to 10% of all non-Hodgkin lymphoma cases in the US, as per the National Cancer Institute at the National Institutes of Health.

Calquence functions by blocking the BTK enzyme which is responsible for multiplication and spreading of the cancer.

The drug was approved through the Accelerated Approval pathway, under which the FDA can approve a drug for serious conditions for which there is unmet medical need and also if it had demonstrated certain effects that are reasonably expected to bring in a clinical benefit to patients.

FDA Oncology Center of Excellence director and FDA Center for Drug Evaluation and Research acting director Richard Pazdur said: “Mantle cell lymphoma is a particularly aggressive cancer.

“For patients who have not responded to treatment or have relapsed, Calquence provides a new treatment option that has shown high rates of response for some patients in initial studies.”

Calquence’s approval was based on the findings from the ACE-LY-004 phase 2 trial held in 124 patients with mantle cell lymphoma who had been treated at least once before for their condition. The trial showed that 81% of patients had a complete or partial response, out of which 40% showed complete response.

According to the FDA, more study is needed to verify and describe expected clinical benefits of Calquence.

A continued approval for Mantle cell lymphoma could depend on the results of confirmatory trials, stated AstraZeneca.

AstraZeneca CEO Pascal Soriot said: “The accelerated approval of Calquence is a landmark moment for our company. It provides an exciting new treatment option for patients with mantle cell lymphoma and marks the first approval of a medicine that will be the cornerstone of our presence in haematology.

“Furthermore, today’s approval demonstrates our commitment to scientific leadership in Oncology and reinforces our progress towards returning to growth.”

Image: AstraZeneca’s Calquence approved by FDA for mantle cell lymphoma. Photo: courtesy of AstraZeneca.