Pfizer Inc., the world’s largest drugmaker, won U.S. regulatory approval of its treatment for one of the four most common types of leukemia.
The Food and Drug Administration cleared the drug, to be known as Bosulif, for adults with previously treated chronic myeloid leukemia who also have an abnormality known as the Philadelphia chromosome, the New York-based company said today in a statement. There are expected to be about 5,400 new cases and 610 deaths from the blood cancer this year, according to the American Cancer Society in Atlanta.
Bosulif will compete with Novartis AG’s Tasigna and Bristol-Myers Squibb Co.’s Sprycel. Pfizer’s treatment is expected to generate $171 million in sales in 2015, according to the average estimate of six analysts compiled by Bloomberg.
“Bosulif is an important new addition to the CML treatment landscape,” Jorge Cortes, a professor of medicine at the University of Texas MD Anderson Cancer Center, and a lead investigator of the Pfizer-sponsored study on the drug, said in the company’s statement. “Despite recent advances, an unmet need remains.”
Treatment is improving based on a better understanding of the molecular basis of the disease, Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement from the agency. The FDA designated Bosulif as an orphan drug, meaning it treats a disease that affects fewer than 200,000 people. Bosulif is chemically known as bosutinib.
This is Pfizer’s third oncology drug approved in the past 13 months, preceded by Xalkori for lung cancer and Inlyta for advanced kidney cancer.
Chronic myeloid leukemia produces an excess of white blood cells. The disease is one of the four main types of leukemia and accounts for 15 percent of all leukemia worldwide, according to Pfizer.
Novartis’s Tasigna generated $716 million in sales last year and Sprycel by Bristol-Myers, based in New York, made $803 million.
Gleevec, from Basel, Switzerland-based Novartis, is the most-popular initial treatment for chronic myeloid leukemia with $4.7 billion in sales last year, according to data compiled by Bloomberg.
Ariad Pharmaceuticals Inc., based in Cambridge, Massachusetts, asked the FDA to review its chronic myeloid leukemia drug ponatinib in July. Ariad said in a July 30 statement that it expects approval in the first quarter of 2013.
Ariad is seeking accelerated approval in patients with resistant or intolerant chronic myeloid leukemia based on the second of three phases of trials typically required for approval on the condition the company proves ponatinib’s benefit in later studies.