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FDA Approves Celgene's Pomalyst For Advanced Multiple Myeloma - Quick Facts

Celgene Corp. (CELG: Quote) announced Friday that the U.S. Food and Drug Administration or FDA has approved POMALYST brand therapy (pomalidomide) for patients with multiple myeloma 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.

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, approximately 21,700 Americans are diagnosed with multiple myeloma and 10,710 die yearly from the disease.

Pomalyst is an analogue of thalidomide, is contraindicated in pregnancy and is only available through a restricted distribution program called POMALSYT REMS. Deep venous thrombosis or DVT and pulmonary embolism (PE) occur in patients with multiple myeloma treated with Pomalyst.

In the study, 219 patients were evaluable for safety. The most common grade 3 or 4 adverse reactions (=15%) in the pomalidomide plus low-dose dexamethasone arm versus pomalidomide alone respectively, were neutropenia (38% and 47%), anemia (21% and 22%), thrombocytopenia (19% and 22%), and pneumonia (23% and 16%).

The company said that Pomalyst will only be available in the United States through POMALYST REMS, a restricted distribution program.

Pomalyst oral therapy comprises pomalidomide, an IMiDs compound. POMALYST and other IMiDs compounds continue to be evaluated in over 100 clinical trials, the company said.

Pomalyst (pomalidomide) is indicated for patients with multiple myeloma 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. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.

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by RTT Staff Writer

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