Patients in the United States who suffer from mantle cell lymphoma have a new treatment option available following the US Food and Drug Administration's (FDA's) decision to grant accelerated approval to Calquence (acalabrutinib). The AstraZeneca Pharmaceuticals drug was granted Priority Review, Breakthrough Therapy, and Orphan Drug designations.
Calquence received approval for use treating adults with mantle cell lymphoma - a rare fast-growing non-Hodgkin lymphoma - who have already received at least one other therapy. It comes following a single-arm clinical trial of 124 patients. The trial found more than eight out of ten (81 percent) of patients had a complete or patrol response to the drug.
"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," said Richard Pazdur, MD, director of the FDA's Oncology Products in the FDA's Center for Drug Evaluation and Research.
Calquence is a kinase inhibitor used to shrink the tumor and thus prevent the spread of cancer. It works by blocking an enzyme needed by the cancer. Other protein kinase inhibitors used to treat cancers are Gleevec (imatinib mesylate) and Cabometyx. Under the Accelerated Approval pathway, further study is required to verify and describe the clinical benefits of Calquence.
Mantle cell lymphoma develops when the body develops abnormal lymphoma cells, which normally help fight infection. The most common symptom of the condition is a painless swelling in the neck, armpit or groin, but other symptoms may include tiredness, weight loss, high temperatures and night sweats. It is usually treated with a combination of chemotherapy drugs and an antineoplastic monoclonal antibody drug called Rituxan (rituximab).
Common side effects of Calquence include:
Fatigue and muscle pain
Reduced levels of platelets, red blood cells and neutrophils
Other possible serious side effects include bleeding, infection, atrial fibrillation, and, on some occasions, other cancers (second primary malignancies).
For more information on Calquence, visit https://www.calquence.com/