News Feature | January 10, 2014

FDA To Approve Leukemia Drug For The Second Time

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By Cassandra Leger

This week the FDA announced it was approving the use of Iclusig to treat leukemia. Iclusig, a product of Ariad Pharmaceuticals, Inc.,  was previously approved by the FDA in 2012 to treat chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia. However, the treatment was limited by the FDA and designated to only be used in patients who did not respond to any other treatment being given to them at the time. Iclusig became a last resort for leukemia sufferers until October 31, 2013, when the FDA asked the manufacturer of the drug to suspend marketing and sales of Iclusig.

The FDA stated that their retraction of approval concerning Iclusig was due to the drug’s life-threatening risks which included serious blood clots. The FDA became concerned with the blood clots’ ability to cause narrowing of blood vessels which could lead to death. In addition, the drug posed an increased threat of heart attack to patients.

The FDA recently revised the labeling of Iclusig and gave the drug approval for use as long as Ariad Pharmaceuticals agreed to revise the product’s label. Ariad is expected to re-enter the drug into the market between January 15 and January 22, 2014. While the drug will once again be used for patients who do not respond to other treatments, it will also be used to treat patients with a specific disease mutation.

The typical treatments for leukemia are Sprycel produced by the Bristol Myers Squibb Company and Gleevel, which is manufactured by Novartis AG. However, in the case these do not work on patients, Iclusig will again be an option. Iclusig’s new label will have to include a warning of clots, heart attack, stokes and even death. The new label must state that these risks have been exhibited by 27% of patients who have used the drug.

Ariad’s Pharmaceutical’s CEO stated that the company will now be treating 1,300 patients annually. During the drug’s last run in the market, it was treating 2,500 patients, suggesting that candidate criteria have been restricted. Initial projections show Iclusig yielding $315 million in revenue over the course of six years.