The Food and Drug Administration announced on Feb. 21 that it had lined up several manufacturers that can provide enough doxorubicin and methotrexate to alleviate current shortages of these vital cancer drugs starting immediately.
Doxorubicin has been in short supply off and on for the last several years. It is approved for use in AIDS-related Kaposi’s sarcoma, multiple myeloma, and ovarian cancer.
Shortages of methotrexate date back at least 5 or 6 years. The most recent methotrexate shortage – which began in November, when the main manufacturer, Ben Venue Laboratories in Bedford, Ohio, had to go off-line due to quality issues – has had an impact on the treatment of acute lymphoblastic leukemia, according to the agency and pediatric oncologists. The New York Times reported on Feb. 10 that hospitals could start running out of methotrexate within 2 weeks.
The restoration of supplies of both drugs "is all good news for patients," said FDA Commissioner Margaret Hamburg at a briefing with reporters. Dr. Hamburg and other FDA officials touted the agency’s proactive moves in addressing the shortages.
For doxorubicin (Doxil), the FDA began looking for alternative manufacturers, although agency officials did not say when. At least one company, Sun Pharma Global FZE, made the drug overseas, said Dr. Sandra Kweder, deputy director in the FDA’s Office of New Drugs, at the briefing. That version of doxorubicin – called LipoDox – is not yet approved in the United States, but the FDA is allowing temporary importation.
The move is largely possible because the company received previous FDA approvals and thus has been subject to FDA inspection before, said Dr. Kweder. "We feel confident in the safety and utility of this product," she said.
With methotrexate, the drug shortage team began working with alternative manufacturers, including Hospira, Mylan, and Sandoz Pharmaceuticals, when Ben Venue began having issues, said Dr. Hamburg.
Ben Venue accumulated some emergency supplies before its shutdown; those will be released soon. Still, it was evident there could be a dire shortage, said Dr. Hamburg.
Preservative-free methotrexate was especially needed for pediatric uses.
Schaumburg, Ill.–based APP Pharmaceuticals is another of the companies that stepped up to help deal with the shortage. The company first ramped up production of methotrexate with preservative, said Mitchell Ehrlich, vice president for quality assurance at APP.
APP then worked with the FDA to expedite review of a generic drug application to produce preservative-free methotrexate. That application was approved on Feb. 17. The company will begin supplying the preservative-free formulation within 4 to 6 weeks, said Mr. Ehrlich.
Hospira, based in Lake Forest, Ill., also ramped up supply and began shipping on Feb. 21, starting with 31,000 vials. That is a 1-month supply, said CEO Michael Ball, at the briefing. The week of Feb. 27, the company will release an additional 34,000 vials, he said. That should be enough to provide a cushion while other companies come on-line.
ASCO: More Needs to Be Done
Also on Feb. 21, the FDA issued draft guidance directing manufacturers and distributors on processes for notifying the agency of problems that could potentially lead to shortages.
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