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.
More articles on pharmacy:
AHA, CVS Health backed secretive anti-pharma group
EpiPen, Humira among drugs Warren wants to regulate
31 drugmakers at high risk for bankruptcy in 2020
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.