Calquence New Treatment Approved for Mantle-Cell Lymphoma

On October 31, 2017, the FDA granted accelerated approval to acalabrutinib (Calquence; AstraZeneca) for the treatment of adults with mantle-cell lymphoma (MCL) who have received at least 1 previous therapy. The FDA granted acalabrutinib priority review and breakthrough therapy and orphan drug designations for this indication.

“Mantle cell lymphoma is a particularly aggressive cancer,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence. “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.” Mantle cell lymphoma is a rare and fast-growing type of non-Hodgkin lymphoma.

The safety and efficacy of acalabrutinib were evaluated in Study LY-004, an open-label, phase 2 study involving 124 patients with MCL who received ≥1 previous therapies. Acalabrutinib 100 mg was administered twice daily until disease progression or until unacceptable toxicity. The primary efficacy end point was overall response rate (ORR), and the median follow-up was 15.2 months. The investigator-assessed ORR was 81% (95% confidence interval, 73%-87%), and the median duration of response was not yet reached.

The most common adverse reactions reported with acalabrutinib include anemia, thrombocytopenia, headache, neutropenia, diarrhea, fatigue, myalgia, and bruising.

Related Articles

Subscribe to
Oncology Practice Management

Stay up to date with oncology news & updates by subscribing to recieve the free OPM print publications or weekly e‑Newsletter.

I'd like to recieve: