Posted from: Tuesday, May 31, 2016 - 03:47 PM - Present

Imbruvica Labeling Expands

May 9, 2016 – The U.S. Food and Drug Administration (FDA) approved a new indication for Imbruvica® (ibrutinib), manufactured by AbbVie and Janssen Biotech. Imbruvica can include an additional indication for treating Small Lymphocytic Lymphoma (SLL) on results from two clinical trials. It already had FDA approvals for treating Mantle Cell Lymphoma (MCL) and Waldenström’s Macroglobulinemia. In March, Imbruvica received a new indication as initial therapy for patients with Chronic Lymphocytic Leukemia (CLL). Additionally, in combination with bendamustine and rituximab, Imbruvica can be used, after one or more previous treatments, for patients where CLL or SLL either came back or did not respond to previous therapy. Imbruvica, an oral Bruton’s tyrosine kinase inhibitor, is taken once a day at varying doses depending on the condition being treated.

 

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Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

 

Last Updated Wednesday, August 23, 2017 - 02:12 PM.