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Roche's Kadcyla (trastuzumab emtansine) Receives FDA's Expanded Approval as an Adjuvant Treatment for HER2+ Early Breast Cancer in the US

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Roche's Kadcyla (trastuzumab emtansine) Receives FDA's Expanded Approval as an Adjuvant Treatment for HER2+ Early Breast Cancer in the US

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  • The approval is based on P-III KATHERINE study results assessing Kadcyla versus Herceptin in patients with HER2+ early breast cancer (eBC) with the residual invasive disease after neoadjuvant treatment included Herceptin and taxane-based CT
  • The P-III KATHERINE study results: reduction in risk of breast cancer recurrence (50%); @3yrs. iDFS (88.3% vs 77.0%); absolute improvement (11.3%); worse prognosis in patients with residual disease after neoadjuvant treatment
  • 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

  Ref: Roche | Image: Roche 

Click here to­ read the full press release 

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