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The US FDA Approves Pfizer’s Tukysa as 1L Maintenance Treatment for HER2+ Metastatic Breast Cancer

Shots:

  • The US FDA has approved Tukysa + trastuzumab & pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic HER2+ breast cancer following induction treatment
  • Approval was supported by the P-III (HER2CLIMB-05) trial data assessing Tukysa (n=326) vs PBO (n=328), both in combination with trastuzumab & pertuzumab, as a maintenance therapy for pts with HER2+ MBC following induction therapy
  • In the P-III trial, Tukysa + trastuzumab & pertuzumab showed a 35.9% reduction in the risk of disease progression or death vs PBO, while the investigator-assessed mPFS was 24.9 vs 16.3mos.; data were published in The JCO

Ref: Businesswire |   Image: Pfizer  |  Press Release

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