Tags : (DS-8201)

AstraZeneca and Daiichi Report the US FDA’s Acceptance of BLA

Shots: The BLA submission is based on P-I study and the pivotal P-II DESTINY-Breast01 study. The P-II DESTINY-Breast01 study assessing Trastuzumab deruxtecan in 253 patients with HER2+ unresectable/metastatic breast cancer prior treated with Trastuzumab Emtansine The US FDA has granted Priority Review to Trastuzumab deruxtecan to treat patients with HER2+ mBC with its expected PDUFA date […]Read More

AstraZeneca and Daiichi Report Results of Trastuzumab Deruxtecan (DS-8201) in

Shots: The P-II DESTINY-Breast01 study involves assessing of Trastuzumab Deruxtecan (DS-8201) in 253 patients with HER2+ unresectable and/or m-breast cancer prior treated with trastuzumab emtansine The P-II DESTINY-Breast01 study result: met its 1EPs; safe & tolerable as in previous trials; supporting the onset of FDA’s BLA submission in H2’19 Trastuzumab Deruxtecan (DS-8201) is an ADC, […]Read More

Daiichi Reports Results of [Fam-] Trastuzumab Deruxtecan (DS-8201) in P-I

Shots: The P-I study involved assessing of [Fam-] trastuzumab deruxtecan (5.4, 6.4 mg/kg) in 46 patients with heavily pretreated HER2 low expressing metastatic breast cancer P-I study results: ORR (44.2 %, 47.4%); disease control rate (79.1%, 81.6%); mDOR (9.4mos., 11.0 mos.); mPFS (7.6 mos., 7.9 mos.) [Fam-] Trastuzumab deruxtecan (DS-8201) is a HER2 targeting antibody […]Read More