FDA Approval: Ado-Trastuzumab Emtansine for the Treatment of Patients with HER2-Positive Metastatic Breast Cancer

Laleh Amiri‐Kordestani(Center for Drug Evaluation and Research), Gideon M. Blumenthal(Center for Drug Evaluation and Research), Qiang Xu(Center for Drug Evaluation and Research), Lijun Zhang(Center for Drug Evaluation and Research), Shenghui Tang(Center for Drug Evaluation and Research), Linan Ha(Center for Drug Evaluation and Research), Wendy C. Weinberg(Center for Drug Evaluation and Research), Bo Chi(Center for Drug Evaluation and Research), Reyes Candau-Chacon(Center for Drug Evaluation and Research), P. E. Hughes(Center for Drug Evaluation and Research), Anne‐Marie Russell(Center for Drug Evaluation and Research), Sarah Pope Miksinski(Center for Drug Evaluation and Research), Xiao Hong Chen(Center for Drug Evaluation and Research), W. David McGuinn(Center for Drug Evaluation and Research), Todd R. Palmby(Center for Drug Evaluation and Research), Sarah J. Schrieber(Center for Drug Evaluation and Research), Qi Liu(Center for Drug Evaluation and Research), Jian Wang(Center for Drug Evaluation and Research), Pengfei Song(Center for Drug Evaluation and Research), Nitin Mehrotra(Center for Drug Evaluation and Research), Lisa Skarupa(Center for Drug Evaluation and Research), Kathleen A. Clouse(Center for Drug Evaluation and Research), Ali Al‐Hakim(Center for Drug Evaluation and Research), Rajeshwari Sridhara(Center for Drug Evaluation and Research), Amna Ibrahim(Center for Drug Evaluation and Research), Robert Justice(Center for Drug Evaluation and Research), Richard Pazdur(Center for Drug Evaluation and Research), Patricia Cortazar(Center for Drug Evaluation and Research)
Clinical Cancer Research
May 31, 2014
10.1158/1078-0432.ccr-14-0012
Cited by 344

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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