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FDA approves drug for multiple myeloma patients resistant to other drugs

Published:Wednesday | November 25, 2015 | 12:01 AM

The United States Food and Drug Administration approved a new drug for multiple myeloma that boosts the immune system in patients who are resistant to other treatments.

The drug, Darzalex, caused reductions in more than a quarter of patients' tumors in clinical trials, which led the agency to speed up its approval.

Multiple myeloma is a type of blood cancer in certain plasma cells in bone marrow that causes weakened bones, a weakened immune system and kidney problems.

"Targeting proteins that are found on the surface of cancer cells has led to the development of important oncology treatments," said Dr Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, in a press release.

"Darzalex provides another treatment option for patients with multiple myeloma who have become resistant to other therapies."




Darzalex attaches to the CD38 surface protein on cancer cells, causing them to die. Two clinical trials found the drug to lower tumor burden in patients. The first study found 29 per cent of patients had a complete or partial reduction in tumors, lasting for an average of 7.4 months, and in the second study, 36 per cent of patients saw the same effect.

"Multiple myeloma is a highly complex disease and remains incurable, with almost all patients relapsing or becoming resistant to therapy," said Dr. Paul Richardson, who led the trials and is director of clinical research at Dana-Farber Cancer Institute, in a press release.

"With Darzalex, we have a promising new immunotherapy, which has shown pronounced efficacy as a single agent with an acceptable adverse event profile. This is especially important for treating these heavily pretreated patients in whom all of the major classes of currently available medicines have failed."