RespiteMatch.com Health Blog

Wed Sep 14, 2005 5:40 PM ET
By Susan Heavey

BETHESDA, Md., Sept 14 (Reuters) - GlaxoSmithKline Plc’s experimental leukemia and lymphoma drug Arranon should be granted accelerated U.S. approval for children and adults, a Food and Drug Administration advisory panel said on Wednesday.

The drugmaker is seeking approval to market the injectable drug to treat patients with a type of leukemia or a type of lymphoma who have not improved with at least two chemotherapy regimens.

The FDA, which usually follows the advice of its advisory panels, is expected to rule by the end of October.

Arranon, known generically as nelarabine, targets a small number of patients.

T-cell acute lymphoblastic leukemia is a harder-to-treat version of the disease, a type of blood and bone marrow cancer in which too many white blood cells are made.

In T-cell lymphoblastic lymphoma, a more serious type of non-Hodgkin’s lymphoma, cancer attacks the immune system’s lymph nodes.

About 1,600 new cases of the diseases are diagnosed each year, and about 500 patients have a relapse, according to Glaxo.

The fatal diseases develop quickly, so getting the drug on the market quickly was key even with limited data, panelists said near-unanimously.

“The severity of the disease doesn’t lend itself to three-to-four years to answer questions,” said panel chairwoman Dr. Silvana Martino, an oncologist at the University of Southern California’s Keck School of Medicine.

While the company’s data was confusing because Arranon patients sometimes also received other therapy, the panel said the disease was so rare that the drug deserved an opportunity to prove it worked. “I think most rational people would say perhaps it deserves a chance at showing that,” said Dr. Thomas Fleming of the University of Washington in Seattle.

Paolo Paoletti, senior vice president for Glaxo’s oncology division, said while the drug would not be a big seller, it would help restart its cancer pipeline. “We will build on that,” he told Reuters.

Shares of Glaxo closed up 42 cents, or nearly one percent, at $50 a share on the New York Stock Exchange.

The FDA is considering the drug under so-called orphan status because of the small number of suitable patients who have few options. Adults are often referred to hospice care, while some children can undergo bone marrow transplants.

Under accelerated approval, drugs can win clearance based on a lower standard of evidence on effectiveness, but companies are supposed to do follow-up studies to confirm the suspected benefits.

Ira Loss of Washington Analysis Corp. said many patients now receive the drug through the National Cancer Institute, which collaborated with Glaxo on the studies. “By making this drug available now commercially, you’re confirming what is already going on,” he said.

Side effects from the injection can include changes in the blood such as fewer white blood cells, platelets and hemoglobin. Headaches, vomiting and fatigue are also possible.