Granted Breakthrough Therapy Designation by FDA2
Indication

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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aAssessed in a single-arm trial of 184 females with HER2+ unresectable and /or mBC who had received ≥2 prior anti-HER2 therapies. Patients received ENHERTU 5.4 mg/kg IV once every 3 weeks until disease progression or unacceptable toxicity. The major efficacy outcomes were confirmed ORR assessed by ICR using RECIST v1.1 and DOR.

bORR (CR+PR) in ITT population. ORR 95% CI calculated using Clopper-Pearson method.1

cDOR based on a median duration of follow-up of 11.1 months. Median DOR based on Kaplan-Meier estimate. 95% CI calculated using Brookmeyer and Crowley method.1

CR, complete response; HER2, human epidermal growth factor receptor 2; ICR, independent central review; ITT, intent-to-treat; mDOR, median duration of response; ORR, objective response rate; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors.