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FDA approval: ado-trastuzumab emtansine for the treatment of patients with HER2-positive metastatic breast cancer.
Amiri-Kordestani, Laleh; Blumenthal, Gideon M; Xu, Qiang Casey; Zhang, Lijun; Tang, Shenghui W; Ha, Linan; Weinberg, Wendy C; Chi, Bo; Candau-Chacon, Reyes; Hughes, Patricia; Russell, Anne M; Miksinski, Sarah Pope; Chen, Xiao Hong; McGuinn, W David; Palmby, Todd; Schrieber, Sarah J; Liu, Qi; Wang, Jian; Song, Pengfei; Mehrotra, Nitin; Skarupa, Lisa; Clouse, Kathleen; Al-Hakim, Ali; Sridhara, Rajeshwari; Ibrahim, Amna; Justice, Robert; Pazdur, Richard; Cortazar, Patricia.
Afiliação
  • Amiri-Kordestani L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland. Laleh.AmiriKordestani@fda.hhs.gov.
  • Blumenthal GM; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Xu QC; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Zhang L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Tang SW; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Ha L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Weinberg WC; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Chi B; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Candau-Chacon R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Hughes P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Russell AM; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Miksinski SP; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Chen XH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • McGuinn WD; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Palmby T; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Schrieber SJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Liu Q; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Wang J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Song P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Mehrotra N; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Skarupa L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Clouse K; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Al-Hakim A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Sridhara R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Ibrahim A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Justice R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
  • Cortazar P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland.
Clin Cancer Res ; 20(17): 4436-41, 2014 Sep 01.
Article em En | MEDLINE | ID: mdl-24879797
ABSTRACT
On February 22, 2013, the FDA licensed ado-trastuzumab emtansine (Kadcyla; Genentech, Inc.) for use as a single agent for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) who previously received trastuzumab and a taxane, separately or in combination. The clinical basis for licensure was a phase III trial in 991 patients with HER2-positive MBC that randomly allocated patients to receive ado-trastuzumab emtansine (n=495) or lapatinib in combination with capecitabine (n=496). The coprimary endpoints were progression-free survival (PFS) based on tumor assessments by an independent review committee and overall survival (OS). Statistically significant improvements in PFS and OS were observed in patients receiving ado-trastuzumab emtansine compared with patients receiving lapatinib plus capecitabine [difference in PFS medians of 3.2 months, HR, 0.65 (95% confidence interval, CI, 0.55-0.77), P<0.0001 and difference in OS medians of 5.8 months, HR, 0.68 (95% CI, 0.55-0.85), P=0.0006]. The most common adverse reactions in patients receiving ado-trastuzumab emtansine were fatigue, nausea, musculoskeletal pain, thrombocytopenia, headache, increased aminotransferase levels, and constipation. Other significant adverse reactions included hepatobiliary disorders and left ventricular dysfunction. Given the PFS and OS results, the benefit-risk profile was considered favorable.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Neoplasias da Mama / Receptor ErbB-2 / Anticorpos Monoclonais Humanizados / Maitansina Idioma: En Ano de publicação: 2014 Tipo de documento: Article
Texto completo
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PubMed Links
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Neoplasias da Mama / Receptor ErbB-2 / Anticorpos Monoclonais Humanizados / Maitansina Idioma: En Ano de publicação: 2014 Tipo de documento: Article