Seattle’s TUKYSA (tucatinib) Receives the US FDA’s Approval for Advanced Unresectable or Metastatic HER2-Positive Breast Cancer
Seattle Genetics’ Adcetris (brentuximab vedotin) Receives FDA’s Breakthrough Designation for Frontline Peripheral T-Cell Lymphomas
Shots:
- 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