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항목
ADCCurated CoreFDAstaleApproved
ado-trastuzumab emtansine (Kadcyla, T-DM1, Trastuzumab Emtansine)
Roche / Genentech·HER2
186 trials
Overview
Program
Kadcyla (ado-trastuzumab emtansine)
Overview
Company
Roche / Genentech
Overview
Modality
ADC
Overview
Target
HER2
Overview
Indication
HER2+ breast cancer
Overview
Phase
APPROVED
Overview
Status
APPROVED
Overview
Content status
Curated Core
Overview
Data Confidence
Editorial scope · Curated Core
Overview
Development Signal
Development Signal · Established
Overview
Approval status
FDA approved
Positioning
Key differentiator
Stable linker, DAR ~3.5
Positioning
Known limitation
HER2 downregulation, lysosomal trapping, and efflux; superseded in 2L HER2+ mBC by trastuzumab deruxtecan (DESTINY-Breast03).
Positioning
Development positioning
2L
Technology
Payload
DM1 (maytansine derivative)
Technology
Linker
Non-cleavable stable thioether MCC
MoA
Mechanism
Ado-trastuzumab emtansine (T-DM1) binds HER2 on tumor cells, is internalized, and MMAE is released after lysosomal degradation of the antibody in the non-cleavable SMCC linker system. MMAE disrupts microtubules, causing G2/M arrest and apoptosis.
MoA
Biomarker
HER2 overexpression/amplification (IHC 3+ or ISH+ per label).
Toxicology
Species
Cynomolgus monkey, Rat
Toxicology
Animal (cat.)
NHP
Toxicology
Major finding
Thrombocytopenia, hepatotoxicity
Toxicology
CRS
Minimal
Clinical
Safety signal
Thrombocytopenia, hepatotoxicity
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Preclinical
Animal (cat.)
In vitro