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Seattle's TUKYSA (tucatinib) Receives the US FDA's Approval for Advanced Unresectable or Metastatic HER2-Positive Breast Cancer

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Seattle's TUKYSA (tucatinib) Receives the US FDA's Approval for Advanced Unresectable or Metastatic HER2-Positive Breast Cancer

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  • The approval is based on HER2CLIMB study assessing TUKYSA in combination with trastuzumab and capecitabine vs trastuzumab & capecitabine monothx in ratio (2:1) in 612 patients with 1L+ Anti-HER2 therapies in the metastatic setting either monothx or in combination- trastuzumab- pertuzumab- and ado-trastuzumab emtansine (T-DM1)
  • The study resulted in 46% reduction in the risk of cancer progression or death (PFS)- OS 34%- objective response (40.6% vs 22.8%); For patients with brain metastases reduction in PFS is 52%. Published in NEJM Dec 2019
  • TUKYSA (tucatinib- PO) is tyrosine kinase inhibitor of the HER2 protein and has also receive the US FDA’s BT Designation and Priority Review for and reviewed this application for approval under the Real-Time Oncology Review (RTOR) pilot program

Click here to read full press release/ article | Ref: Seattle | Image: Behance


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