publication date: Nov. 3, 2017

Drugs and Targets

FDA approves AstraZeneca’s Calquence for mantle cell lymphoma

AstraZeneca and its hematology research and development center of excellence, Acerta Pharma, said the FDA has granted accelerated approval to Calquence (acalabrutinib, previously known as ACP-196), a kinase inhibitor, for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.

Calquence, an inhibitor of Bruton tyrosine kinase (BTK), is approved based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

The approval is based on data from the ACE-LY-004 trial, a phase II open-label, single-arm clinical trial in 124 adult patients with relapsed or refractory MCL. In the trial, 81 percent of patients had a complete or partial response (40 percent complete response, 41 percent partial response).

Common side effects of Calquence include headache, diarrhea, bruising, myalgia, anemia, thrombocytopenia, and neutropenia. Serious side effects include hemorrhage, infections, and atrial fibrillation. Second primary malignancies have occurred in some patients taking Calquence.

“Mantle cell lymphoma is a particularly aggressive cancer,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “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.”

Full results from the ACE-LY-004 clinical trial have been submitted for presentation at a forthcoming medical meeting, the company said.

This will be the first MCL trial data to be presented from the acalabrutinib development program, which includes both monotherapy and combination therapies in a broad range of blood cancers and … Continue reading FDA approves AstraZeneca’s Calquence for mantle cell lymphoma

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