Kadcyla® is the commercial brand name of Trastuzumab Emtansine for Injection, an antibody-drug conjugate combining anti-HER2 trastuzumab and cytotoxic DM1. It binds specifically to HER2 expressed on tumor cells, internalizes and releases DM1 to disrupt microtubule network and induce tumor cell death.
Main Indications
Treatment of HER2-positive early breast cancer and HER2-positive unresectable locally advanced or metastatic breast cancer in adults who have received prior HER2-targeted therapy.
Clinical Research
Global pivotal phase III studies showed Kadcyla significantly prolonged progression-free survival and overall survival compared with standard chemotherapy in patients with HER2-positive metastatic breast cancer progressed after trastuzumab and taxane;
Bridging trials in Chinese patients validated consistent efficacy and safety data with global population;
Additional clinical investigations evaluated its role in adjuvant therapy for residual invasive disease after neoadjuvant treatment.
Common Side Effects
Severe but important risks: Left ventricular ejection fraction decline, hepatotoxicity, interstitial lung disease, severe thrombocytopenia;
Common mild adverse reactions: Fatigue, nausea, musculoskeletal pain, headache, constipation, dry eye and peripheral neuropathy.
Approval Status in China
Kadcyla® (Trastuzumab Emtansine for Injection, specification:100mg per vial) was officially approved for marketing in China. It is currently a prescription antibody-drug conjugate.
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