FDA Approves Label Update for Imbruvica Used to Treat Rare Form of nonHodgkin’s Lymphoma

Abbvie and Janssen have received FDA approval to include new safety and efficacy data with the prescribing information for Imbruvica (ibrutinib), when used with rituximab for the treatment of Waldenström's macroglobulinemia (WM), a rare, incurable form of nonHodgkin’s lymphoma.

The new data are from a final analysis of a phase 3 study in which the drug combination lowered the risk of disease progression or death by 75 percent vs. rituximab alone after 63 weeks.

Imbruvica is the only Bruton’s tyrosine kinase (BTK) inhibitor approved for treating the rare cancer. It received FDA clearance as a monotherapy for WM in 2015 and as a combination therapy with rituximab in 2018.