Colon cancer drug shortage raises concerns

There is not a large enough supply of a major colorectal cancer chemotherapy medication, Forbes reports today. The drug is leucovorin, an injectable generic chemotherapy medication, and the shortage could mean thousands of patients will go without treatment and could halt studies of new experimental drugs as well.

Patients have received Teva Pharmaceuticals' and Bedford Laboratories' leucovorin to improve the effectiveness of another cancer drug, 5-flurouracil (5FU), for three decades, but last month the FDA reported that there were manufacturing delays that were affecting the available supplies of the medication. Its use increased when it was discovered that when patients received leucovorin with 5FU, the number who saw a reduction in tumor size tripled. The regimen is a mainstay in colorectal cancer treatment today.

The supply is so short that a committee at the prestigious University of California-San Francisco is holding weekly meetings to ration the supply, which oncologist Alan Venook says "the average patient" is not receiving. In addition, newer medications like Erbitux and Avastin have undergone all testing with the drug.

Groups that coordinate cancer drug clinical trials convened via conference call yesterday to try to come up with a solution to the shortage of the drug, which is a modified B vitamin.

While neither Teva nor Bedford have commented publicly on the shortage thus far, the American Society of Health System Pharmaceuticals confirmed that there is a backorder for the drug and that neither company can say when they will be able to meet the demand.  Information about the shortage and the potential for its remedy is scarce and it remains unclear to what degree the shortage will affect the 140,000-plus Americans who receive a colorectal cancer diagnosis each year. 

- read the story at 
- see the Pharmalot blog entry
- find the Wall Street Journal blog post