Posted by Michael Wonder on 26 Sep 2016
AbbVie announces submission of a supplemental new drug application for Ibrutinib (imbruvica) for treatment of marginal zone lymphoma
26 September 2016 - If approved by the U.S. FDA, ibrutinib will be the first therapy specifically approved for patients with marginal zone lymphoma, a slow-growing form of non-Hodgkin's lymphoma, and the fifth new treatment indication for the medication.
AbbVie today announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. FDA for ibrutinib (Imbruvica) to treat patients with marginal zone lymphoma (MZL). MZL is a slow-growing form of non-Hodgkin's lymphoma. The Company's sNDA submission is based on data from a multi-center, open-label Phase II PCYC-1121-CA trial assessing ibrutinib as a single-agent treatment for MZL.
If approved, MZL will be the fifth unique type of blood cancer indication for Imbruvica.
Imbruvica is jointly developed and commercialized by Pharmacyclics, an AbbVie company and Janssen.
