General MedicationsSINGLE-USEStandard
KADCYLA
ADO-TRASTUZUMAB EMTANSINE
Standard Dose
160MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview KADCYLA is listed in Drugs@FDA under application 125427 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ADO-TRASTUZUMAB EMTANSINE Form and strength VIAL; SINGLE-USE - 160MG Sponsor GENENTECH Submission history Latest submission status date: 2026-03-26 00:00:00.
Structured Monograph
Clinical summary
Approval overview KADCYLA is listed in Drugs@FDA under application 125427 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient ADO-TRASTUZUMAB EMTANSINE Form and strength VIAL; SINGLE-USE - 160MG Sponsor GENENTECH Submission history Latest submission status date: 2026-03-26 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.