This is important news. Most don’t realize that Doxil (doxorubicin hydrochloride) was the 4th drug approved by the FDA for use in multiple myeloma patients back in 2006. Kyprolis (carfilzomib) was the next myeloma drug approved over six years later last July. Doxil doesn’t get a lot of love, partly because it is strictly an assisting drug, used to enhance Velcade and/or Revlimid, and partly because it has been in short supply for over a year following a shut-down of it’s primary manufacturing location.
Remember the big flap over how cancer patients were dying due to a chemotherapy drug shortage last year? Doxil was one of the primary casualties, made more serious because the drug is used to treat a variety of cancers, not just multiple myeloma.
It would be good to get it back as a change-of-pace treatment option; sort of like Cytoxan.
FDA Approves Generic Version of Doxil To Ease Shortage
Clinical Oncology News – March, 2013
On Feb. 4, the FDA approved the first generic version of doxorubicin hydrochloride (HCl) liposome injection to ease an ongoing shortage of the cancer drug, the agency announced in a press release. For products on the FDA’s drug shortage list, the agency’s Office of Generic Drugs uses a priority review system to expedite review of generic applications.
The newly approved medication is made by Sun Pharma Global FZE, and is the generic equivalent to Doxil (Janssen Products, LP). The drug will be available in 20- and 50-mg vials, according to the press release. Doxorubicin HCl liposome injection is administered intravenously and indicated, under certain conditions, for ovarian cancer, AIDS-related Kaposi’s sarcoma and multiple myeloma, according to the drug’s prescribing information.
“The agency is committed to doing everything we can to address drug shortages so that patients can get the medicines they need when they need them,” Capt. Valerie Jensen, RPh, the director of Drug Shortage Staff at the FDA’s Center for Drug Evaluation and Research, said in a statement. “For the past year, the FDA has been working to ensure that supplies of doxorubicin hydrochloride liposome injection were not interrupted.”
Part of those efforts by the agency included a decision in February 2012 to allow temporary importation of Lipodox, a branded version of doxorubicin HCl liposome injection that also is produced by Sun Pharma, along with its distributor, Caraco Pharmaceutical Laboratories Ltd. The FDA stressed, however, that Lipodox is not approved for marketing in the United States; the agency used its regulatory enforcement discretion to allow importation of the drug during the Doxil shortage.
For the present time, the FDA will continue to allow importation of Lipodox. However, once supplies of Sun Pharma’s approved version of the drug are sufficient to meet projected demand, the agency said it expects to reinstate its ban on importing any unapproved doxorubicin HCl liposomal product.
Janssen Products, which is the sole U.S.-based supplier of doxorubicin HCl liposome injection, has stated that manufacturing issues are to blame for the ongoing shortages of Doxil. Updates on the drug’s availability can be obtained at http://www.doxilsupply.com/index.html.
Myeloma specialists have gotten out of the habit of using Doxil. And I believe shortages derailed a number of ongoing clinical studies.
Will docs start using it again once it becomes readily available? My guess is yes. One more wrinkle to try and buy us all a little more time.
Feel good and keep smiling! Pat