Richard Pazdur, MD
The approval was based on data from the 722-patient phase III TOURMALINE-MM1 trial, which showed a median progression-free survival (PFS) of 20.6 months with ixazomib plus lenalidomide and dexamethasone compared with 14.7 months with lenalidomide and dexamethasone alone. Additionally, a substantial increase in adverse events was not observed with the addition ixazomib.
"As we learn more about the underlying biology of multiple myeloma, we are encouraged to see the development of new ways to treat this disease," Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research, said in a statement. "Today's approval is the third drug for multiple myeloma approved this year and provides patients with a new oral treatment that slows disease progression when other therapy has failed." Click here to read the full article at OncLive.com