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

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Leukemia drug Imbruvica snagged another approval from the U.S. Food and Drug Administration (FDA). The regulatory agency gave the greenlight 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.

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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.

Danelle James, head of clinical science at Pharmacyclics LLC, an AbbVie company, said that there have been significant advances made in the treatment of cancer over the past few years, particularly blood cancers. James said the combination of Imrbuvica and Gazyva is an example of that innovation.

“I am proud that we can now give physicians and patients a new option to treat CLL and SLL without the need for chemotherapy,” James said.

Chronic lymphocytic leukemia is one of the two most common forms of leukemia in adults and is a type of cancer that can develop from cells in the bone marrow that later mature into certain white blood cells called lymphocytes. While these cancer cells start in the bone marrow, they then spread into the blood. There are an estimated 115,000 CLL patients in the U.S., with about 20,000 new diagnoses each year. Small lymphocytic lymphoma (SLL) is a slow-growing lymphoma similar to CLL in which too many immature white blood cells cause lymph nodes to become larger than normal. Both CLL and SLL are predominately diseases of the elderly, with a median age of diagnosis ranging from 65-70 years.

In addition to the new approval, the FDA also updated the Imbruvica label to include additional long-term efficacy follow-up supporting its use as a single agent in CLL/SLL, the company said.

The latest approval for Imbruvica comes about five months after the last indication approved by the FDA. In August, the regulatory agency approved Imbruvica in combination with Roche’s Rituxan for the treatment of adult patients with Waldenström's macroglobulinemia (WM), which is a rare and incurable type of non-Hodgkin's lymphoma (NHL). That approval represents the “first and only chemotherapy-free combination treatment” specifically indicated for that rare blood disease. Like CLL and SLL, Waldenström's macroglobulinemia (WM) typically affects older adults and is primarily found in the bone marrow.

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