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FDA Approves Expanded Indication for Carfilzomib in Patients with Multiple Myeloma

August 24, 2015, by NCI Staff

Multiple myeloma cells are abnormal plasma cells that build up in the bone marrow and form tumors in many bones of the body.

Credit: Terese Winslow

On July 24, the Food and Drug Administration (FDA) approved carfilzomib (Kyprolis®), given in combination with lenalidomide and dexamethasone, to treat patients with relapsed multiple myeloma who have previously received at least one prior treatment.

The FDA initially approved carfilzomib in 2012, under its accelerated approval program, for use alone in patients with multiple myeloma whose cancer has progressed after receiving at least two previous therapies, including bortezomib and an immunomodulatory agent (such as lenalidomide or thalidomide).

"Relapse is almost universal with myeloma. Some patients enjoy long durations of remission after their first treatment, but very few patients can be cured today," explained Mark Roschewski, M.D., of the Lymphoid Malignancies Branch in NCI’s Center for Cancer Research.

Relapses appear to relate to the ability of some cancer cells to resist treatment and persist for long periods, he continued. "Thus, remission is not synonymous with cure."

The latest approval was based on the results of a large randomized clinical trial that showed that patients who received carfilzomib in combination with lenalidomide and dexamethasone had longer progression-free survival than those who received lenalidomide and dexamethasone alone: 23.6 months versus 17.6 months.

Common side effects that occurred most often in patients taking the three-drug combination included fatigue, low blood cell count, low blood platelet levels, diarrhea, and fever.

“This approval highlights the importance of using combinations of drugs in patients with relapsed myeloma,” Dr. Roschewski said.

“In this case, it's a combination of three drugs that have demonstrated the ability to get deeper and more durable remissions,” he added. “This will serve as an important benchmark for designing clinical trials that attempt to improve upon these impressive results.”

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