Genzyme asks FDA for adult use for leukemia drug
Cambridge biotechnology company Genzyme Corp. said today that it has asked the Food and Drug Administration to approve its leukemia drug Clolar for adults.
The drug is already approved for a form of the disease called acute lymphoblastic leukemia in patients between 1 and 21 years old who have had at least two prior treatments.
Genzyme asked that the FDA give priority review to the drug as an initial treatment for adults with acute myeloid leukemia. If granted, the FDA would review the drug application within six months, meaning it could have a decision in the first half of 2009.
The company is also developing the drug for other forms of leukemia, which could eventually drive peak annual sales to $600 million. Leukemia is a cancer that affects the blood or bone marrow.
Shares of Genzyme fell 8 cents to $67.13 in afternoon trading on the Nasdaq Stock Market. (AP)