An extended shortage of mechlorethamine hydrochloride, a nitrogen mustard used in chemotherapy for hematologic cancers - and for treating mycosis fungoides - is expected to begin this month, the Food and Drug Administration announced today.
The limited supply of mechlorethamine hydrochloride (Mustargen) will be allocated to patients already being treated with the chemotherapy drug, the agency said in a statement advising that "alternative treatment plans should be made for new patients to avoid interruption to a treatment program that would normally include Mustargen."
Once the current supply of Mustargen is depleted in mid to late April, the shortage of the drug is expected to last until "early 2011," according to the FDA. The existing supply will be distributed by Lundbeck Inc., the only manufacturer of the agent in the world, "to meet current patient needs, with priority given to sites with patients currently receiving Mustargen." No other supplies could be found.
Mustargen, the first chemotherapy drug approved by the FDA in 1949, is a component of the MOPP (Mustargen, Oncovin, procarbazine, and prednisone) regimen pioneered in the mid 1960s for advanced Hodgkin's disease. It is still used as a treatment for Hodgkin's disease, alone or in combination with radiation, as well as for polycythemia vera, mycosis fungoides, and bronchogenic carcinoma.
In an April 1 letter to healthcare professionals, Dr. Mark Weinberg, vice president of U.S. medical affairs at Lundbeck, said the remaining supply of Mustargen is "very limited in terms of quality and dating." The company will make the product available until the inventory is depleted, and is encouraging physicians to "consider alternative therapy rather than starting a new course of therapy with Mustargen," he added.
The shortage is related to unsuccessful attempts to transfer the manufacturing of Mustargen to a new manufacturer over the past several years, and the recent decision by a new contractor not to pursue commercial manufacturing, according to the letter. The company is transferring the manufacturing to another site, and is "confident" that the new manufacturer will produce a "high quality product." That is not expected to be approved before 2011, however.