The FDA approved Nov. 21 AstraZeneca's drug, Calquence, designed to treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma.
The approval was part of a collaboration between the FDA, the Australian Therapeutic Goods Administration and Health Canada, known as Project Orbis.
Chronic lymphocytic leukemia and small lymphocytic lymphoma are similar cancers but they occur in different areas of the body. Chronic lymphocytic leukemia mainly occurs in blood and bone marrow and small lymphocytic lymphoma occurs mainly in the lymph nodes.
In a clinical trial, chronic lymphocytic leukemia patients had longer progression-free survival compared to patients receiving other standard treatments.
The most common side effects are anemia, neutropenia, upper respiratory tract infection, low platelet levels, headache, diarrhea and musculoskeletal pain.
The FDA advised providers to monitor patients taking Calquence for symptoms of irregular heartbeat and irregular bleeding. Patients may have low blood counts and should have their blood tested regularly.
Patients may also experience serious infections and should be monitored and treated promptly.
The FDA advised patients taking Calquence to use sun protection, as other malignancies including skin cancers and other solid tumors have occurred in patients taking Calquence.
The agency also advised providers to tell females of reproductive age to use effective contraception during treatment with Calquence, as it may cause harm to a developing fetus or newborn baby, or cause delivery complications.
The FDA granted Calquence priority review and breakthrough therapy designation.
Read the full news release here.
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