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Celgene (CELG) Advanced Multiple Myeloma Drug Receives FDA Approval

 February 08, 2013 04:19 PM

(By Balaseshan) Celgene Corp. (NASDAQ: CELG) said the U.S. Food and Drug Administration (FDA) has approved oral therapy to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs.

Pomalyst is a pill that modulates the body's immune system to destroy cancerous cells and inhibit their growth. It is intended for patients who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy.

In July 2012, FDA approved Onyx Pharmaceuticals Inc.'s (NASDAQ: ONXX) Kyprolis (carfilzomib) to treat multiple myeloma. Similar to Kyprolis, Pomalyst is being approved under the agency's accelerated approval program.

[Related -Celgene Corporation (NASDAQ:CELG): Why Should You Invest In Celgene In 2014?]

The company said approval is based on response rate and the clinical benefit, such as improvement in survival or symptoms, has not been verified.

Common side effects include a decrease in infection-fighting white blood cells (neutropenia), fatigue and weakness, low red blood cell count (anemia), constipation, diarrhea, low levels of platelets in the blood (thrombocytopenia), upper respiratory tract infections, back pain and fever.

Pomalyst carries a Boxed Warning alerting that the drug should not be used in pregnant women because it can cause severe life-threatening birth defects, and it can cause blood clots.

[Related -Celgene Corporation (CELG): How Q3 Earnings Will Fare?]

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

CELG closed Friday's regular session up 2.35% at $100.13. The stock has been trading between $58.53 and $102.29 for the past 52 weeks.

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