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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