Calquence Approved for Mantle Cell Lymphoma
Mantle cell is an aggressive, fast-growing non-Hodgkin lymphoma, a cancer of the lymph system. Though it represents only 3 percent to 10 percent of non-Hodgkin cases in the United States, the cancer usually has spread by the time it's detected, the FDA said in a news release on Tuesday.
"For patients who have not responded to treatment or who have relapsed, Calquence provides a new treatment option that has shown high rates or response for some patients in initial studies," said Dr. Richard Pazdur, director of the agency's Oncology Center of Excellence.
Calquence is a kinase inhibitor that's designed to block an enzyme that cancer cells use to multiply, the FDA said.
The drug was evaluated in a clinical study of 124 people with mantle cell lymphoma who had received at least one prior treatment. Some 81 percent of trial participants given the drug had a complete or partial response.
The most common side effects included headache, diarrhea, bruising, muscle pain and low red blood cell count (anemia). More serious adverse reactions included bleeding, infections, irregular heartbeat and other cancers, the FDA said.
Calquence is produced by AstraZeneca, based in the United Kingdom.
The FDA has more about this approval.
Posted: October 2017