Chugai Files an Application to MHLW for an Additional Indication of Kadcyla (trastuzumab emtansine) as an Adjuvant Therapy for HER2-Positive Early Breast Cancer in Japan

Chugai’s Risdiplam Receives MHLW’s Orphan Drug Designation for Spinal Muscular Atrophy (SMA)


  • The application is based on P-III KATHERINE study assessing Kadcyla as adjuvant therapy vs Herceptin in ~ 1,500 patients with HER2+ early breast cancer who had invasive residual disease in the breast or axillary lymph nodes following neoadjuvant therapy including Herceptin
  • The P-III KATHERINE study results: superiority in invasive disease-free survival as confirmed; no superiority in OS; well tolerated in patients with HER2+ early breast cancer. Chugai plans to expand its HER2 portfolio with the approval of the new indication
  • Kadcyla is a combination of Herceptin and CT medicine emtansine and has received FDA’s BT designation, an approved therapy in the US to treat HER2+ m-BC and & early-stage HER2+ BC after surgery, prior treated with Herceptin and Taxane CT

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