FDA Panel Recommends Leukine for Leukemia Treatment
WASHINGTON (AP) _ A panel of scientists has recommended the government approve the drug Leukine to help certain leukemia patients survive the immune-killing chemotherapy necessary to fight their disease.
Aggressive chemotherapy is the standard treatment for acute myelogenous leukemia, the most common acute leukemia in adults. But the chemotherapy kills vital white blood cells, and consequently patients often die of infections before their immune systems recover.
Immunex Corp. says studies show its drug Leukine, which helps regenerate white blood cells, reduces life-threatening infections from 36 percent in untreated patients to 10 percent. Three of the 52 patients who tested Leukine died of infections, versus 11 of 47 leukemia patients who took a placebo.
If the Food and Drug Administration follows the advice of its advisory committee, Leukine would become the first growth factor approved for these patients.
The advisory committee, late Monday, also recommended that Leukine be approved to help regenerate the immune cells of patients undergoing a bone marrow transplant from a donor.
Leukine is already approved for use following autologous bone marrow transplants, where patients store their own bone marrow for later use.
If the FDA agrees, the two new indications would increase Leukine’s market from 6,000 patients a year to 25,000, said Immunex chief executive Ed Fritzky. Leukine’s sales currently are $45 million a year.
However, the FDA advisors didn’t recommend that Leukine be approved for use following chemotherapy for other cancers. Immunex said it will meet with FDA to see what other data it must show to get that approval to treat an additional 100,000 patients a year.
Wall Street investors were apparently disappointed by the latter decision. Immunex stock was down $2.12 1/2 a share at $13.50 in midday trading on the New York Stock Exchange.