New Indication for Imbruvica
The U.S. FDA approved Imbruvica (ibrutinib) as breakthrough therapy for Waldenström’s macroglobulinemia (WM), a rare type of non-Hodgkin lymphoma most common among older adults. Usually a slowly progressing type of cancer, WM causes enlargement of the liver, lymph nodes and spleen. Over production of M protein by the cancer cells causes blood to become dense, often leading to heart problems, nerve damage, stroke-like symptoms, vision changes and continual seepage of blood from the gums and nose. Imbruvica was previously indicated to treat patients who have had previous therapy for mantle cell lymphoma, who have tried other drugs for chronic lymphocytic leukemia (CLL), and who have CLL with a specific chromosomal abnormality. The recommended dosing for Imbruvica to treat WM is 420mg (three 140mg capsules) taken once a day.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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