Kadcyla in a New Indication – Adjuvant Therapy for Early HER2+ Breast Cancer
In December, the European Commission approved the expansion of the indication for Roche's medicinal product Kadcyla, which contains the active substance trastuzumab emtansine. This expansion makes adjuvant treatment accessible to a much larger number of patients with early HER2-positive breast cancer and reduces the likelihood of disease recurrence or progression.
Expansion of Indication
Before the indication expansion, trastuzumab emtansine as monotherapy was indicated for the treatment of adult patients with HER2+ unresectable locally advanced or metastatic breast cancer who were previously treated with trastuzumab and a taxane, either alone or in combination. Patients were either previously treated for locally advanced or metastatic disease, or experienced disease recurrence during adjuvant therapy, or within 6 months following its completion.
Trastuzumab emtansine is now newly indicated for the adjuvant treatment of adult patients with early HER2+ breast cancer who have residual invasive disease in the breast and/or lymph nodes following neoadjuvant taxane-based therapy and anti-HER2 therapy. The goal of adjuvant therapy is to eliminate remaining cancer cells in the body, thereby reducing the likelihood of disease recurrence.
Results of the KATHERINE Study
Approval of this indication expansion by European authorities followed its approval in the United States in May 2019. The medicinal product (MP) Kadcyla is currently approved in this new indication in 27 countries worldwide.
The decision was based on results from the pivotal multicenter randomized open-label phase III KATHERINE study, which compared trastuzumab emtansine (Kadcyla) with trastuzumab (Herceptin) in adjuvant therapy. The likelihood of invasive breast cancer recurrence or death from any cause was reduced by 50% in patients treated with trastuzumab emtansine. After 3 years of follow-up, 88% of patients treated with trastuzumab emtansine were free from disease recurrence, compared to 77% recurrence-free in the trastuzumab group.
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Source: EMA. Kadcyla: Assessment report. EMA, 2020 Jan 20. Available at: www.ema.europa.eu/en/documents/variation-report/kadcyla-epar-h-c-2389-ii-0045-epar-assessment-report-variation_en.pdf
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