FDA, companies working to increase short supply of leukemia drug

February 16, 2012

FDA and 3 drug manufacturers say they are working to allay the concerns of health organizations that thesupply of methotrexate -- used to treat acute lymphoblastic leukemia in children – is in danger of running out

FDA and 3 drug manufacturers say they are working to allay the concerns of health organizations that thesupply of methotrexate -- used to treat acute lymphoblastic leukemia in children – is in danger of running out.

The American Society of Clinical Oncology (ASCO) is among several groups that say they are worried that production problems with methotrexate could cause the supply to run out in the near future.

However, Valerie Jensen, associate director of FDA’s Drug Shortage program, said in a recent news report that the situation may be resolved before that happens. In addition, 3 manufacturers of the drug – Hospira Inc., Sandoz U.S., and Mylan – all say they have stepped up production of methotrexate.

“We are working both on the manufacturing and regulatory fronts to expedite the FDA regulatory approvals necessary to further increase capacity to the extent possible to support the additional demand,” Mylan said it a statement.

Hospira said it is working with FDA to qualify a second supplier of the drug’s active ingredient.

“Hospira believes that it can increase its supply to the market if it can secure additional methotrexate active ingredient supply,” according to a statement from the company. “Hospira is doing everything it can to help bring more product to market.”

ASCO President Michael Link, MD, commended FDA, Mylan, and Hospira, on their efforts to avert the shortage. “ASCO hopes that other companies follow suit to prioritize availability of this drug, that is necessary to sustain the dramatic cure rates for acute lymphoblastic leukemia,” Link said.