AbbVie (ABBV) announced that the U.S. FDA approved IMBRUVICA plus RITUXAN for the treatment of adult patients with Waldenstrom’s macroglobulinemia, a rare and incurable type of non-Hodgkin’s lymphoma. With this approval, the IMBRUVICA prescribing information now includes combination use with rituximab, representing the first and only chemotherapy-free combination treatment specifically indicated for the disease. IMBRUVICA was first approved as a single agent therapy for WM in January 2015. IMBRUVICA is a first-in-class Bruton’s tyrosine kinase inhibitor jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech (JNJ).
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