Trastuzumab Emtansine · Kadcyla, PRO-132365

What is Trastuzumab Emtansine?

Trastuzumab emtansine is an antibody-drug conjugate of the anti-HER2 antibody trastuzumab linked to the microtubule inhibitor DM1. After binding HER2 and internalization, released DM1 binds tubulin, disrupting microtubules, causing cell cycle arrest and apoptotic death. It is studied in HER2-positive breast cancer, ovarian, cervical, lung and melanoma tumors.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as

Kadcyla, PRO-132365, RG-3502, T-DM1

Drug type

Antibody-drug conjugate

Targets

HER2 (ERBB2) (ERBB2), tubulin (secondary target)

Mechanism

Cytotoxic, directed at HER2 (ERBB2) (ERBB2)

Pathways

HER2 receptor signaling inhibition, microtubule disruption, cell cycle arrest, apoptosis, antibody-dependent cell-mediated cytotoxicity

Therapy area

Oncology

Developer

Genentech, Inc.

In trials of

ASND, ELVN, PBYI

FDA status

Approved as Kadcyla (February 22, 2013), BLA125427 · FDA label

UNII

SE2KH7T06F

✅ FDA-approved uses

• HER2-positive metastatic breast cancer
• HER2-positive early breast cancer

From the indications section of the FDA label (version of Apr 1, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

2L+ Cervical CancerAdvanced Solid TumorHER2 Mutant Non-small Cell Lung CancerHER2-positive Metastatic Breast CancerLocally Advanced Solid TumorMetastatic Solid TumorNeoadjuvant MelanomaNeoadjuvant Non-Small Cell Lung CancerPlatinum-resistant Ovarian CancerPost Anti-PD-(L)1 Non-Small Cell Lung CancerPost Anti-PD-(L)1 Small Cell Lung CancerPost Anti-PD-1 MelanomaSecond or Third Line (2L/3L) Cervical CancerThird Line or Later (3L+) HER2+ Breast Cancer

Other drugs acting on ERBB2

Sources

• FDA Purple Book
• FDA label (DailyMed)
• FDA label Kadcyla (2026-04-01), indications
• NCI Thesaurus
• ClinicalTrials.gov NCT02236000
• ClinicalTrials.gov NCT05081609

Updated Oct 11, 2026.