Company wins approval for lymphoma drug
NEW YORK (AP) – U.S. regulators have approved a new treatment for people with a rare form of non-Hodgkin lymphoma.
The Food and Drug Administration granted accelerated approval to AstraZeneca PLC’s Calquence for people with mantle cell lymphoma after chemotherapy or other treatments fail. The British drugmaker is now conducting further testing required by the FDA to confirm the drug’s benefits and risks.
Mantle cell lymphoma is a blood cancer that usually strikes middle-aged people and the elderly. By the time it’s diagnosed, it usually has spread to the lymph nodes, bone marrow and other organs, according to the FDA.
About 4,200 Americans are diagnosed with the cancer each year. Median survival is about five to seven years, according to the Leukemia and Lymphoma Society. But treatment has been improving in recent years with the addition of targeted drugs and stem cell therapy to chemotherapy.
“Mantle cell lymphoma is a particularly aggressive cancer,” Dr. Richard Pazdur, director of the FDA’s oncology center of excellence, said in a statement.