JHVEPhoto The FDA has granted expanded approval for Amgen’s ( NASDAQ: AMGN ) Blincyto for the treatment of certain adult and pediatric patients with acute lymphoblastic leukemia, or ALL. More specifically, the agency approved the drug for patients aged one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia, or B-ALL, in the consolidation phase, regardless of measurable residual disease, or MRD, status. Amgen noted the drug is the only bispecific T cell engager, or BiTE, therapy for consolidation treatment regardless of MRD status.
Previously, Blincyto was approved for the treatment of CD19-positive B-ALL in the first or second complete remission with MRD greater than or equal to 0.1% in adults and children aged one year or older. It was also approved for relapsed or refractory CD-19 positive B-ALL in adults and children aged one month or older.
The drug is also approved in the EU for various CD19-postive B-ALL indications. More on Amgen Amgen Inc. (AMGN) Goldman Sachs 45th Annual Global Healthcare Conference Transcript Amgen Is A Fantastic Dividend Growth Stock With A Weight-Loss Wild Card Amgen Stock: Poised To Break Out (Technical Analysis) Amgen posts late-stage win for Uplizna in immune-mediated disorder SA Asks: Which weight-loss stocks should investors be watching?.
