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.