Treats HER2-positive, metastatic breast cancer. BLA 125427, held by Genentech. Ado-Trastuzumab Emtansine.
As of Nov 14, 2026, BLA 125427 (Kadcyla), held by Genentech, was first approved by FDA on Feb 22, 2013, with 13 approved supplements and 0 published complete response letters.
KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for: the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy. the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Select patients for therapy based on an FDA-authorized test for KADCYLA 1.
| May 14, 2025 | Supplement 121Efficacy (new indication or use) · Standard review | Approved | |
| May 3, 2019 | Supplement 105Efficacy (new indication or use) · Priority review | Approved | |
| Feb 22, 2013 | Original applicationNew molecular entity · Priority review | Approved |
| Kadcyla100MG · vial; single-use | Ado-Trastuzumab Emtansine | Rx |
| Kadcyla160MG · vial; single-use | Ado-Trastuzumab Emtansine | Rx |
| Mar 26, 2026 | Supplement 125Labeling · Standard review | Approved | |
| May 14, 2025 | Supplement 121Efficacy (new indication or use) · Standard review | Approved | |
| Feb 2, 2022 | Supplement 111Labeling · Standard review | Approved | |
| Sep 27, 2020 | Supplement 108Labeling · Standard review | Approved | |
| May 3, 2019 | Supplement 105Efficacy (new indication or use) · Priority review | Approved | |
| Dec 18, 2018 | Supplement 104Labeling · Standard review | Approved | |
| Sep 20, 2018 | Supplement 102Labeling · Standard review | Approved | |
| Jul 25, 2016 | Supplement 96Labeling · Standard review | Approved | |
| Apr 28, 2016 | Supplement 94Labeling · Standard review | Approved | |
| May 29, 2015 | Supplement 87Labeling · Standard review | Approved | |
| Jul 11, 2014 | Supplement 33Labeling · Standard review | Approved | |
| Aug 29, 2013 | Supplement 14Labeling · Standard review | Approved | |
| Aug 19, 2013 | Supplement 12Labeling · Standard review | Approved | |
| Feb 22, 2013 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
