The medicine was cleared to treat chronic lymphocytic leukemia, the second therapy for the deadly disease to come to market in the last few months, the Food and Drug Administration said today in a statement. Roche Holding AG (ROG)’s Gazyva gained FDA approval in November for CLL. Both were deemed breakthrough drugs by the FDA.
Almost 16,000 new cases of CLL are expected to be diagnosed this year, which totals about one-third of leukemia cases, according to the American Cancer Society. The FDA approved Imbruvica in November for mantle cell lymphoma patients who have tried other treatments. Peak sales for the pill may reach $6.5 billion in 2026, with $3 billion coming from the U.S., said Michael Yee, an analyst with RBC Capital Markets.
Chronic lymphocytic leukemia starts in white blood cells in the bone marrow, according to the Atlanta-based American Cancer Society. An estimated 4,600 CLL patients will die this year from the disease, the advocacy group said.
A final phase study of Imbruvica’s effect on CLL patients’ survival was stopped early based on results showing the medicine helped patients live longer without their cancer progressing compared with GlaxoSmithKline Plc (GSK)’s Arzerra, Sunnyvale, California-based Pharmacyclics and New Brunswick, New Jersey-based J&J said in statements Jan. 7.
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