FDA Gives Greenlight to Janssen and AbbVie's Imbruvica for the 10th Time

Leukemia drug Imbruvica snagged another approval from the U.S. Food and Drug Administration (FDA). The regulatory agency gave the green light for Imbruvica combined with Gazyva for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma. The approval of the combination marks a first for the U.S. market. The combination of AbbVie and Janssen’s Imbruvica with Roche’s Gazyva is the first chemotherapy-free, anti-CD20 combination to treat CLL and SLL patients who have not yet started therapy, AbbVie said this morning. This is the tenth approval for Imbruvica since it was first approved in 2013 as a treatment for adult patients with Mantle cell lymphoma, a subtype of non-Hodgkin's lymphoma.
The approval is based on results from the Phase III iLLUMINATE study that showed the combination treatment significantly improved progression-free survival (PFS) compared to chlorambucil plus obinutuzumab in previously untreated CLL/SLL patients who were 65 years or older, or less than 65 years old with coexisting conditions. Trial results showed that patients who were treated with the combination of Imbruvica and Gazyva experienced a 77 percent reduction in risk of progression or death compared to the chemotherapy arm. AbbVie said the chemotherapy-free, anti-CD20 combination regimen also showed an 85 percent reduction in risk of progression or death compared to chlorambucil plus obinutuzumab when evaluating PFS in patients with high-risk disease.

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