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Drug to treat form of leukemia wins approval
By Catholic Online (NEWS CONSORTIUM)
September 5th, 2012
Catholic Online (www.catholic.org)
September 5th, 2012
Catholic Online (www.catholic.org)
The Food and Drug Administration has approved a pill that treats a rare form of leukemia. The drug's approval is being seen as a major step in increasing drug manufacturer Pfizer, Inc. oncology business.
LOS ANGELES, CA (Catholic Online) - Called Bosulif, the drug treats chronic myelogenous leukemia, or CML. The affliction is a blood and bone marrow disease that typically affects older adults. It's estimated that about 26,000 Americans live with this form of cancer, and 5,430 people in the United States are usually diagnosed with the disease annually, the FDA said.People afflicted with CML have a specific type of genetic mutation called the Philadelphia chromosome. This mutation causes bone marrow to make an enzyme that triggers the abnormal growth of white blood cells.
Bosulif, known generically as bosutinib, works to block the enzyme's signal that causes the white blood cells to grow.
"We are seeing improvements in the treatment of CML based on a better understanding of the molecular basis of the disease," Dr. Richard Pazdur, head of the FDA's cancer drugs center says.
The new drug is intended for people who have CML in connection with the Philadelphia mutation who cannot tolerate other medicines. The drug will also benefit patients whose cancer has stopped responding to older treatments.
The FDA gave Bosulif "orphan status," meaning it treats a condition or disease that affects fewer than 200,000 people in the U.S. This designation will give Pfizer a seven-year period of marketing exclusivity.
Analysts polled by Thomson Reuters say the medicine is expected to reach peak global sales of $341 million in 2016.
Bosulif is the second Pfizer cancer drug to get the FDA's approval this year, following its kidney cancer drug Inlyta. Investors are looking for signs of the company's research productivity, to help replace lost revenue from its cholesterol fighter Lipitor. This comes as welcome news for Pfizer, as it has begun facing generic competition last year.
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