EC Approves Amgen's BLINCYTO for Treatment of Adults with Philadelphia Chromosome-Negative Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia

Amgen

today announced that the European Commission (EC) has granted conditional marketing authorization for BLINCYTO® (blinatumomab) for the treatment of adults with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL). Experience the interactive Multimedia News Release here: http://www.multivu.com/players/English/7414058-amgen-blincyto-europe-approval/  ALL is a rare and rapidly progressing cancer of the blood and bone marrow.1,2 For adults with relapsed or refractory ALL, the median overall survival is just three to five months.3 It is estimated that the incidence of adults with Ph- relapsed or refractory B-precursor ALL in the European Union (EU) is approximately 900 patients per year.4 "We are pleased the European Commission granted conditional marketing authorization for BLINCYTO," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "BLINCYTO has demonstrated efficacy in treating relapsed or refractory ALL, a very difficult-to-treat disease for which historically patients had limited therapeutic options. This approval represents an important milestone in immunotherapy research. BLINCYTO is the first clinical validation of the BiTE® platform, a new and innovative approach that helps the body's own immune system fight cancer." The conditional