The US Food & Drug Administration is issuing a warning to multiple myeloma patients and health care providers about what it sees as a link between multiple myeloma patients, maintenance use of Revlimid, and the incidence of secondary cancer development.
After reviewing three separate clinical trials involving patients newly diagnosed with multiple myeloma who underwent chemotherapy and a stem cell transplantation followed by maintenance therapy with Revlimid, the FDA says it sees a three-fold increased risk among those patients of developing a second, primary cancer.
Specifically, the agency found 65 second primary cancers in 824 Revlimid patients and 19 among 665 patients in those trials who did not receive Revlimid.
In percentages, the difference is 7.9% compared to 2.8% (P<0.001), a statistically significant figure.
Common second primary cancers included acute myelogenous leukemia, myelodysplastic syndromes, and B-cell malignancies, according to FDA reports.
Notably, trials that involved multiple myeloma patients with relapsed or refractory disease taking Revlimid did not bear out this same risk.
The FDA intends to put this additional risk on the drug's label as well as its medication guide.
Source: Medpage Today
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