Posted from: Monday, October 08, 2018 - 12:25 PM - Present

New Lymphoma Indication for Imbruvica

August 27, 2018 – The U.S. FDA has approved a new indication for Imbruvica® (ibrutinib), manufactured by Pharmacyclics and Janssen, to for use in conjunction with Rituxan® (rituximab), manufactured by Genentech, to treat Waldenström’s macroglobulinemia (WM).

Also known as lymphoplasmacytic lymphoma, WM is a rare form of non-Hodgkin lymphoma. The disease begins in B cells, which normally respond to infections by creating antibody proteins. When these cells become cancerous WM cells, they create an excessive amount of macroglobulin, a type of antibody. Symptoms of WM include fever, weight loss, and neuropathy (caused by nerve damage). In the United States, an estimated 1,000 to 1,500 people are diagnosed with WM annually. Reported median survival times range from five years to 11 years.

The recommended dosing with Imbruvica under the new indication is 420mg once daily. Rituxan should be given at a dose of 375mg/m2 once each week for four weeks via intravenous (IV) infusion. This should be followed by three months without Rituxan, and then another month of once-weekly infusions. When Rituxan and Imbruvica are taken on the same day, patients should receive their Imbruvica first. In a clinical trial, 82% of patients on this regimen experienced progression-free survival times of at least 30 months compared to 28% of patients treated with Rituxan and placebo.

Imbruvica first received FDA approval in 2013, and is approved to treat several types of lymphoma. Rituxan received approval in 1997. It is indicated for treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

Last Updated Friday, October 19, 2018 - 04:37 PM.