A SEVERE shortage of a childhood cancer drug should ease before hospitals run out of it in a couple weeks, a top federal regulator said .
But the companies that make the drug are giving few details about how they will find a long-term solution to end the problem.
Valerie Jensen, associate director of the Food and Drug Administration's drug shortage programme, said her team was working with the three makers of preservative-free methotrexate, which is used to treat the most common childhood cancer, acute lymphoblastic leukemia, or ALL.
The drug, which cures up to 90% of children with ALL, has been in very short supply in recent weeks in America because a leading maker of the drug shut down some of its factories late last year.
Hospitals have warned the FDA that treatments for children with ALL could be stalled if new shipments of the drug aren't received within a couple weeks. That could lessen the chances of children being cured of the disease.
"We understand from all three companies that they will be starting to ship by the end of the month," Jensen said.
The three manufacturers of the drug - Mylan, Hospira and Sandoz - weren't specific about how they plan to resolve the shortage of the cancer medicine.
APP Pharmaceuticals, which makes a form of methotrexate with preservative, said it was working with the FDA to determine whether it could get approval for a preservative-free formula.
The preservative-free version is needed by both children and adults when methotrexate is given in very high doses intravenously or by injection in spinal fluid.
Dr Peter Adamson, chairman of the Children's Oncology Group, a network of 200-plus North American hospitals treating children with cancer, said FDA officials "have been reassuring in discussions that this is not going to be a prolonged shortage." Still, he said: "Until the drug is actually delivered, we can't be sure."
Until late last year, five drugmakers in the US manufactured the generic injected cancer medicine methotrexate, which is crucial for treating children and adults with ALL as well as children with other, less-common cancers.
Four of those companies made a preservative-free version. So, when one of the biggest makers of the preservative-free methotrexate, Ben Venue Laboratories Inc. recently shut down its four factories in Bedford, Ohio, possibly for a year, due to serious quality problems, the on-again, off-again methotrexate shortage that began in late 2008 quickly turned into a crisis.
Some hospitals and cancer specialists say they still have enough methotrexate to treat current patients. But a January survey of 204 oncologists around the country found at least 40% believed that one or more patients in the past year had either died prematurely or suffered a tumor recurrence because of the cancer drug shortages.
End to kids' cancer drug shortage still uncertain
A SEVERE shortage of a childhood cancer drug should ease before hospitals run out of it in a couple weeks, a top federal regulator said .
But the companies that make the drug are giving few details about how they will find a long-term solution to end the problem.
Valerie Jensen, associate director of the Food and Drug Administration's drug shortage programme, said her team was working with the three makers of preservative-free methotrexate, which is used to treat the most common childhood cancer, acute lymphoblastic leukemia, or ALL.
The drug, which cures up to 90% of children with ALL, has been in very short supply in recent weeks in America because a leading maker of the drug shut down some of its factories late last year.
Hospitals have warned the FDA that treatments for children with ALL could be stalled if new shipments of the drug aren't received within a couple weeks. That could lessen the chances of children being cured of the disease.
"We understand from all three companies that they will be starting to ship by the end of the month," Jensen said.
The three manufacturers of the drug - Mylan, Hospira and Sandoz - weren't specific about how they plan to resolve the shortage of the cancer medicine.
APP Pharmaceuticals, which makes a form of methotrexate with preservative, said it was working with the FDA to determine whether it could get approval for a preservative-free formula.
The preservative-free version is needed by both children and adults when methotrexate is given in very high doses intravenously or by injection in spinal fluid.
Dr Peter Adamson, chairman of the Children's Oncology Group, a network of 200-plus North American hospitals treating children with cancer, said FDA officials "have been reassuring in discussions that this is not going to be a prolonged shortage." Still, he said: "Until the drug is actually delivered, we can't be sure."
Until late last year, five drugmakers in the US manufactured the generic injected cancer medicine methotrexate, which is crucial for treating children and adults with ALL as well as children with other, less-common cancers.
Four of those companies made a preservative-free version. So, when one of the biggest makers of the preservative-free methotrexate, Ben Venue Laboratories Inc. recently shut down its four factories in Bedford, Ohio, possibly for a year, due to serious quality problems, the on-again, off-again methotrexate shortage that began in late 2008 quickly turned into a crisis.
Some hospitals and cancer specialists say they still have enough methotrexate to treat current patients. But a January survey of 204 oncologists around the country found at least 40% believed that one or more patients in the past year had either died prematurely or suffered a tumor recurrence because of the cancer drug shortages.
Would you like to comment on this article?
Register (it's quick and free) or sign in now.
Please read our Comment Policy before commenting.
Trending
Latest Videos