Pharmacyclics Inc. and Johnson & Johnson won U.S. approval for their breakthrough cancer drug Imbruvica to treat a second blood cancer.
The medicine was cleared for chronic lymphocytic leukemia patients who have tried at least one other treatment, the second therapy for the deadly disease to come to market in the last four months, the Food and Drug Administration said today in a statement. Roche Holding AG’s Gazyva gained FDA approval in November for CLL patients who hadn’t been treated for the cancer. The FDA classified both as breakthrough drugs.
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.
“Today’s approval provides an important new treatment option for CLL patients whose cancer has progressed despite having undergone previous therapy,” Richard Pazdur, director of the FDA’s Office of Hematology and Oncology Products, said in the statement. “The FDA completed its review of Imbruvica’s new indication under the agency’s accelerated approval process, which played a vital role in rapidly making this new therapy available to those who need it most.”
Pharmacyclics, based in Sunnyvale, California, rose 3.1 percent to $137 at the close in New York. J&J fell less than 1 percent to $92.42.
The FDA cleared Imbruvica based on the condition Pharmacyclics and J&J prove it has clinical benefit. While a trial showed the drug helped shrink the cancer in patients, the companies haven’t yet shown regulators that the therapy extends survival or improves symptoms.
A final phase study of Imbruvica’s effect on CLL patients’ survival was stopped early last month based on results showing the medicine helped patients live longer without their cancer progressing compared with GlaxoSmithKline Plc’s Arzerra, Pharmacyclics and New Brunswick, New Jersey-based J&J said in statements Jan. 7.
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.