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FDA Approval: Gemtuzumab Ozogamicin for the Treatment of Adults with Newly Diagnosed CD33-Positive Acute Myeloid Leukemia.
Jen, Emily Y; Ko, Chia-Wen; Lee, Jee Eun; Del Valle, Pedro L; Aydanian, Antonina; Jewell, Charles; Norsworthy, Kelly J; Przepiorka, Donna; Nie, Lei; Liu, Jiang; Sheth, Christopher M; Shapiro, Marjorie; Farrell, Ann T; Pazdur, Richard.
Affiliation
  • Jen EY; Center for Drug Evaluation and Research, U.S. Food and Drug Administration. Emily.Jen@fda.hhs.gov.
  • Ko CW; Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
  • Lee JE; Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
  • Del Valle PL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
  • Aydanian A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
  • Jewell C; Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
  • Norsworthy KJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
  • Przepiorka D; Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
  • Nie L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
  • Liu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
  • Sheth CM; Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
  • Shapiro M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
  • Farrell AT; Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
  • Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
Clin Cancer Res ; 24(14): 3242-3246, 2018 07 15.
Article in En | MEDLINE | ID: mdl-29476018

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Leukemia, Myeloid, Acute / Drug Approval / Sialic Acid Binding Ig-like Lectin 3 / Antineoplastic Agents, Immunological / Gemtuzumab Type of study: Clinical_trials / Diagnostic_studies Limits: Adult / Humans Language: En Journal: Clin Cancer Res Journal subject: NEOPLASIAS Year: 2018 Type: Article

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Leukemia, Myeloid, Acute / Drug Approval / Sialic Acid Binding Ig-like Lectin 3 / Antineoplastic Agents, Immunological / Gemtuzumab Type of study: Clinical_trials / Diagnostic_studies Limits: Adult / Humans Language: En Journal: Clin Cancer Res Journal subject: NEOPLASIAS Year: 2018 Type: Article