Yesterday morning I wrote an article about how the FDA had approved denosumab (Xgeva) for use in some cancers, but not multiple myeloma. The Myeloma Beacon also published a story about denosumab later yesterday evening:
Myeloma Beacon reporter Julie Shilane was able to interview someone from the FDA about the decision: “It (denosumab) wasn’t approved (for myeloma) because the Xgeva-treated subset of multiple myeloma patients had more deaths than the control arm,” said Erica Jefferson, a spokesperson for the Food and Drug Administration (FDA).
Don’t you hate when that happens! Why would more multiple myeloma patients die during the study than other cancer patients? An anomaly? Wasn’t the study large enough? Or is the answer more complicated than that?
There is more to this story. Stay tuned.
Feel good and keep smiling! Pat