Celgene (CELG) Wins FDA Approval for Pomalyst in Multiple Myeloma

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Celgene (CELG) Affirms Approval of Pomalyst for Multiple Myeloma Patients

February 8, 2013 3:56 PM EST

Celgene Corporation (Nasdaq: CELG) announced the U.S. Food and Drug Administration (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.

Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.

Supporting the approval were the results of MM-002, a phase II,... More

Approval of Celgene's (CELG) Pomalyst Largely Expected by Street (ONXX)

February 8, 2013 6:57 AM EST

Celgene's (Nasdaq: CELG) Pomalyst (pomalidomide) might have some potential after all.

According to a recent Bloomberg survey of five analysts, Pomalyst is likely to win FDA approval for the treatment of multiple myeloma in patients who have failed at least two prior... More