US FDA warns on safety of Celgene's Revlimid; new Ph III trial results

The US Food and Drug Administration this week issued a notification of an increased risk of second primary malignancies (new types of cancer) in patients with newly-diagnosed multiple myeloma who received drugmaker Celgene (Nasdaq: CELG) Revlimid (lenalidomide).

Clinical trials conducted after Revlimid was approved showed that newly-diagnosed patients treated with Revlimid had an increased risk of developing second primary malignancies compared to similar patients who received a placebo. Specifically, these trials showed there was an increased risk of developing acute myelogenous leukemia, myelodysplastic syndromes and Hodgkin lymphoma, the FDA said.

This safety information has been added to the Warnings and Precautions section of the Revlimid drug label. The patient Medication Guide is also being updated to inform patients about this risk. Health care professionals should consider both the potential benefit of Revlimid and the risk of second primary malignancies when deciding to treat patients with this drug, and monitor patients for this risk, the FDA stated.