AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) Receive the FDA’s Accelerated Approval for HER-2 Positive Unresectable/ Metastatic Breast Cancer

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) Receive the FDA’s Accelerated Approval for HER-2 Positive Unresectable/ Metastatic Breast Cancer

Shots:

  • The accelerated approval is based on P-II DESTINY-Breast01 study assessing Enhertu (5.4mg/kg) as monothx. in 184 patients with HER2-positive mBC, prior treated with two or more anti-HER2 based regimens in the metastatic setting at 100+ sites globally
  • The P-II DESTINY-Breast01 study results: ORR (60.3%); CR (4.3%); PR (56.0%); mDOR (14.8mos. as of Aug 01, 2019); mPFS (16.4mos.)
  • Enhertu is a HER2-directed ADC, currently being evaluated in three ongoing P-III studies for exploring its potential in other indications. The regulatory submission has been made to the MHLW based on DESTINY-Breast01 and P-I studies

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