The FDA today announced a series of steps to increase the supply of critically needed cancer drugs and build on President Obama’s Executive Order to help prevent future drug shortages. In response to the critical shortage of the cancer drug Doxil (doxorubicin hydrochloride liposome injection; Janssen Biotech) and rapidly declining supplies of methotrexate, the FDA took proactive steps needed to increase available supply for patients in the U.S.
For Doxil, there will be temporary importation of a replacement drug, Lipodox (doxorubicin hydrochloride liposome injection; Sun Global Pharma), which is expected to end the shortage and fully meet patient needs in the coming weeks. For methotrexate, in addition to already announced actions, the Agency has approved a new manufacturer of preservative-free formulation of methotrexate that is expected to further bolster supply and help avert a shortage of this lifesaving medicine. FDA expedited review of the application to help address this potential shortage.
Under the FDA’s exercise of enforcement discretion the chemotherapeutic drug Lipodox will be imported as an alternative to Doxil. Doxil is used in multiple treatment regimens, including treatment of ovarian cancer after failure of platinum-based chemotherapy. The drug is also indicated for use in AIDS-related Kaposi’s sarcoma and multiple myeloma. The FDA anticipates that the incoming supply of Lipodox will be able to fully meet patient needs. Temporary importation of unapproved foreign drugs is considered in rare cases when there is a shortage of an approved drug that is critical to patients and the shortage cannot be resolved in a timely fashion with FDA-approved drugs.
With regard to methotrexate, a drug that is needed for the treatment of many forms of cancer and other serious diseases, the FDA has successfully engaged many firms to assist in maintaining supplies to meet all patient needs. Preservative-free methotrexate is needed for the intrathecal treatment of children with acute lymphocytic leukemia (ALL) and for the high-dose therapy of osteosarcoma.
For more information regarding the Doxil and methotrexate shortage visit www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM292634.pdf.