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 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)

Shots:

  • 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

Click here to­ read full press release/ article | Ref: Chugai Pharmaceutical | Image: Twitter

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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