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FDA Grants Accelerated Multiple Myeloma Drug Approval

Pomalyst (Celgene Corp.)

Pomalyst (Celgene Corp.)

The U.S. Food and Drug Administration approved pomalidomide to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. Pomalidomide is marketed under the brand name Pomalyst by the pharmaceutical company Celgene Corporation in Summit, New Jersey.

Multiple myeloma is a blood cancer that affects mainly older adults and arises from plasma cells in the bone marrow. According to National Cancer Institute, some 21,700 Americans are diagnosed with multiple myeloma and 10,710 die each year from the disease.

Pomalyst is a small-molecule drug taken as a pill to modulate the body’s immune system, and destroy cancerous cells and inhibit their growth. The drug is intended for patients who have received at least two prior therapies, including the drugs lenalidomide and bortezomib, and whose disease did not respond to treatment, and progressed within 60 days of the last treatment.

The safety and effectiveness of Pomalyst were tested in a clinical trial of 221 patients with relapsed or refractory multiple myeloma, and were randomly given Pomalyst alone or Pomalyst with low-dose of the drug dexamethasone, a corticosteroid. The effects of the drug were measured by the number of patients achieving complete or partially disappearance of their cancer after treatment.

Results of the trial indicate 7.4 percent of patients treated with Pomalyst alone achieved partial or complete cancer disappearance. The median duration of response has not yet been reached in these patients. In patients treated with Pomalyst plus low-dose dexamethasone, 29 percent achieved partial or complete cancer disappearance with a median duration of response of 7.4 months.

FDA says it approved the drug under its accelerated approval process to give patients earlier access to new drugs while the drug’s developers complete studies to confirm its safety and clinical benefits. Pomalyst was also designated an orphan drug because it treats a rare disease or condition.

Pomalyst is an analogue of thalidomide, which has proven risks for causing severe birth defects. The drug comes with a boxed warning that the drug should not be taken by pregnant women because it can cause birth defects as well as blood clots.

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