FDA Approves Imbruvica For Expanded CLL Indication

The U.S. Food and Drug Administration announced that it has approved an indication expansion for Janssen Biotech’s and Pharmacyclics’ Imbruvica (ibrutinib).Imbruvica is an oral once-daily therapy that works to inhibit Bruton's tyrosine kinase (BTK), a signaling molecule implicated in the survival and spread of malignant B cells. The drug previously received approval in 2013 under Breakthrough Therapy status for three types of cancer.

However, this week, the FDA has approved Imbruvica for the treatment of patients with chronic lymphocytic leukemia (CLL) with a deletion in chromosome 17 (17p deletion), caused by poor responses to current CLL treatments. The approval was based on the results of a clinical study showing that the drug reduced risk of disease progression or death by 78 percent.

“We continue to see advances in the availability of therapies to treat chronic lymphocytic leukemia, especially for difficult-to-treat patient populations. Imbruvica is the fourth drug approved to treat CLL that received a breakthrough therapy designation,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Danelle James, VP of Clinical Development at Pharmacyclics, said, “We are delighted Imbruvica has received full approval by demonstrating its ability to improve progression-free survival and, importantly, overall survival as compared to an approved standard of care, and that Imbruvica is now available to all patients with del 17p CLL.”

After 22 years of not getting a drug to the market and trading company stock for less than $1 in 2008, Pharmacyclics’ shares climbed to more than 140 percent over the last year following the announcement. The company was valued at $9.1 billion in 2013, thanks to the drug’s positive performance in a Phase III clinical trial, (effectively pitting it against GlaxoSmithKline and Genmab drugs), and Imbruvica’s subsequent approval.

The new FDA approval requires $60 million in milestone payments to Pharmacyclics according to its collaboration agreement with Janssen Biotech.