FDA Warns of Revlimid Cancer Link in Multiple Myeloma

The US Food & Drug Administration will be putting a warning on the drug Revlimid, stating that for some multiple myeloma patients, taking the drug raises the risk of developing a second, primary cancer.

After reviewing data from three clinical trials, the FDA has found that the incidence of second, primary cancers among newly diagnosed multiple myeloma patients who were treated with chemotherapy, a stem cell transplant, and then Revlimid maintenance therapy is three times higher than among patients not receiving the Revlimid.

They found that the incidence of second primary cancer is statistically significant--7.9% compared to 2.8% (p<0.001).

The secondary cancers most frequently diagnosed were acute myelogenous leukemia, myelodysplastic syndromes, and B-cell lymphomas.

Patients with relapsed or refractory multiple myeloma who received Revlimid were not included, as the incidence rate was not found to be significant.

Source: Medpage Today