US FDA approves Pfizer leukemia drug
Last Updated: 2012-09-04 18:45:06 -0400 (Reuters Health)
WASHINGTON (Reuters) - U.S. health regulators on Tuesday approved Pfizer Inc's Bosulif (bosutinib) to treat chronic myelogenous leukemia (CML), a disease that usually affects older adults.
Most people 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 blocks 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, said in a statement.
Pfizer's drug is meant for people who have CML with the Philadelphia mutation who cannot tolerate other medicines, such as Novartis AG's Gleevec, or whose cancer has stopped responding to the older treatments.
The FDA gave Bosulif orphan status, which means it treats a condition or disease that affects fewer than 200,000 people in the United States. The designation comes with a seven-year period of marketing exclusivity.
About 26,000 Americans live with the cancer, and 5,430 people in the United States expected to be diagnosed with it annually, the U.S. Food and Drug Administration said.
Copyright © 2012 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.