EC expands approval of Amgen's Blincyto; FDA gives uniQure green signal to begin Huntington's study in humans, Cytokinetics feedback on SMA trial
→ The first therapy to win approval for cancer patients in remission with minimal residual disease in Europe is Amgen‘s $AMGN BiTE immunotherapy, Blincyto. The drug’s EC approval has been expanded to include certain patients with acute lymphoblastic leukemia in first or second complete remission with minimal residual disease (MRD) – the presence of cancer cells that remain detectable despite remission – greater than or equal to 0.1%. The EC approval is based on data from the Phase II BLAST study, which demonstrated the drug led to no detectable MRD, in 78 percent of patients within one treatment cycle. The EC nod follows a similar FDA approval last March.
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