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Trastuzumab emtansine

Generic Name
Trastuzumab emtansine
Brand Names
Kadcyla
Drug Type
Biotech
CAS Number
1018448-65-1
Unique Ingredient Identifier
SE2KH7T06F

Overview

Trastuzumab emtansine, formerly called Trastuzumab-DM1 (T-DM1) is a first-in-class HER2 antibody drug conjugate (ADC) comprised of Genentech's trastuzumab antibody linked to ImmunoGen's cell-killing agent, DM1. T-DM1 combines two strategies-- anti-HER2 activity and targeted intracellular delivery of the potent anti-microtubule agent, DM1 (a maytansine derivative)--to produce cell cycle arrest and apoptosis. Trastuzumab emtansine is marketed under the brand name Kadcyla and is indicated for use in HER2-positive, metastatic breast cancer patients who have already used taxane and/or trastuzumab for metastatic disease or had their cancer recur within 6 months of adjuvant treatment. The FDA label has two precautions. First that trastuzumab emtansine and trastuzumab cannot be interchanged. Second that there is a black box warning of serious side effects such as hepatotoxicity, embryo-fetal toxicity, and cardiac toxicity.

Background

Trastuzumab emtansine, formerly called Trastuzumab-DM1 (T-DM1) is a first-in-class HER2 antibody drug conjugate (ADC) comprised of Genentech's trastuzumab antibody linked to ImmunoGen's cell-killing agent, DM1. T-DM1 combines two strategies-- anti-HER2 activity and targeted intracellular delivery of the potent anti-microtubule agent, DM1 (a maytansine derivative)--to produce cell cycle arrest and apoptosis. Trastuzumab emtansine is marketed under the brand name Kadcyla and is indicated for use in HER2-positive, metastatic breast cancer patients who have already used taxane and/or trastuzumab for metastatic disease or had their cancer recur within 6 months of adjuvant treatment. The FDA label has two precautions. First that trastuzumab emtansine and trastuzumab cannot be interchanged. Second that there is a black box warning of serious side effects such as hepatotoxicity, embryo-fetal toxicity, and cardiac toxicity.

Indication

Used in HER2-positive, metastatic breast cancer patients who have already used taxane and/or trastuzumab for metastatic disease or had their cancer recur within 6 months of adjuvant treatment.

Associated Conditions

  • HER2-Positive Early Stage Breast Cancer
  • HER2-positive, Metastatic Breast Cancer

FDA Approved Products

KADCYLA
Manufacturer:Genentech, Inc.
Route:INTRAVENOUS
Strength:20 mg in 1 mL
Approved: 2023/08/31
NDC:50242-087
KADCYLA
Manufacturer:Genentech, Inc.
Route:INTRAVENOUS
Strength:20 mg in 1 mL
Approved: 2023/08/31
NDC:50242-088

Singapore Approved Products

KADCYLA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 160MG/VIAL
Manufacturer:F. Hoffmann-La Roche Ltd (Bulk Production, Primary Packager)
Form:INJECTION, POWDER, FOR SOLUTION
Strength:160 mg/vial
Online:Yes
Approved: 2014/01/24
Approval:SIN14496P
KADCYLA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL
Manufacturer:F. Hoffmann-La Roche Ltd (Bulk Production, Primary Packager)
Form:INJECTION, POWDER, FOR SOLUTION
Strength:100 mg/vial
Online:Yes
Approved: 2014/01/24
Approval:SIN14497P

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