The US Food and Drug Administration (FDA) has approved Imbruvica (ibrutinib) to treat mantle cell lymphoma (MCL), which strikes some 4,200 Americans a year.
MCL is a fast growing cancer that’s usually not detected before it has already spread to the lymph nodes, bone marrow and other organs.
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Imbruvica is approved to treat MCL patients who have already received at least one other therapy.
The medication works by attacking the enzyme the cancer uses to grow and spread.
Imbruvica was approved under the FDA’s Breakthrough Therapy Designation program, which speeds up approval of medicines that preliminary clinical evidence shows to be substantially more effective than available therapies in treating serious or life-threatening diseases.
According to the FDA, this program provides earlier patient access to promising new medications while the company conducts confirmatory clinical trials.
Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement, “The agency worked cooperatively with the companies to expedite the drug’s development, review and approval, reflecting the promise of the Breakthrough Therapy Designation program.”
The approval is based on a study involving 111 MCL patients who were given Imbruvica daily until their disease progressed or side effects became too much to bear.
Nearly 66 percent of these patients saw their cancer shrink or disappear after treatment with the medication. Survival data and disease-related symptoms have not yet been established.
The FDA reported that the most common side effects reported in participants receiving Imbruvica included low levels of platelets in the blood, decrease in infection-fighting white blood cells, anemia, nausea, bruising, diarrhea, constipation, fatigue, respiratory infections, abdominal pain, vomiting, decrease in appetite, swelling (edema), musculoskeletal pain and shortness of breath.
Other clinically significant side effects included infections, bleeding, kidney problems and the development of other types of cancers.
Imbruvica is marketed by Pharmacyclics and Janssen Biotech, Inc.