Roche’s Kadcyla (trastuzumab emtansine) Receives CHMP’s Recommendation for Approval as an Adjuvant Treatment for Patients with HER2+ eBC with Residual Invasive Disease After Neoadjuvant Treatment

Roche’s Kadcyla (trastuzumab emtansine) Receives CHMP’s Recommendation for Approval as an Adjuvant Treatment for Patients with HER2+ Early Breast Cancer with Residual Invasive Disease After Neoadjuvant Treatment

Shots:

  • The CHMP’s recommendation is based on P-III KATHERINE study assessing Kadcyla vs Herceptin as an adjuvant therapy in patients with HER2+ early breast cancer with the residual invasive disease after neoadjuvant treatment which included Herceptin and Taxane-based CT
  • The P-III KATHERINE study results: reduction in iDFS by 50%; @3yrs. iDFS (88.3% vs 77.0%) showing absolute improvement of 11.3%; AEs (25.7% vs 15.4%)
  • Kadcyla (trastuzumab emtansine) is an ADC, a combination of trastuzumab and DM1, delivering CT directly to HER2+ cancer cells. It has received approval in 104 countries including the US & EU for HER2+ m-breast cancer and is developed using ADC technology licensed from ImmunoGen

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