Patients suffering from multiple myeloma, a cancer of the blood cells, may soon get a new treatment option if officials from the U.S. Food and Drug Administration and the European Medicines Agency expand XGEVA to treat the illness.
The U.S. FDA has accepted Amgen’s supplemental Biologics License Application (sBLA) for BLINCYTO (blinatumomab) to include overall survival data from the Phase 3 TOWER study, Amgen said in a press release.
The life expectancy of leukemia patients may be nearly doubled by the use of Amgen’s new immunotherapy drug, according the results of a clinical trial published March 1 in the New England Journal of Medicine.
Amgen has announced a phase-three study analyzing how XGEVA competes with zoledronic acid when it comes to meeting the primary endpoint of non-inferiority in delaying the time to first on-study skeletal-related event (SRE) in patients with multiple myeloma.
Amgen recently announced that its research has revealed new data for Imlygic (talimogene laherparepvec) to treat melanoma and metastatic colorectal cancer, stating that the information will be presented at the European Society for Medical Oncology 2016 Congress.
The Committee for Medicine Products for Human Use (CHMP) branch of the European Medicines Agency recently granted a positive opinion to broaden the indication of Amgen’s Kyprolis (carfilzomib) treatment for relapsed multiple myeloma.