FDA D.I.S.C.O. Burst Edition: FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2-positive solid tumors
Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval.
On April 5, 2024, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (brand name Enhertu) for adult patients with unresectable or metastatic HER2-positive solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
Efficacy was evaluated in 192 adult patients with previously treated unresectable or metastatic HER2-positive solid tumors who were enrolled in one of three multicenter trials: DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02. All three trials excluded patients with a history of interstitial lung disease/pneumonitis requiring treatment with steroids or interstitial lung disease/pneumonitis at screening and clinically significant cardiac disease. Patients were also excluded for active brain metastases or ECOG performance status greater than 1. Treatment was administered until disease progression, death, withdrawal of consent, or unacceptable toxicity.
The major efficacy outcome measure in all three trials was confirmed objective response rate, and an additional efficacy outcome was duration of response. All outcomes were assessed by independent central review based on RECIST v1.1. In DESTINY-PanTumor02, objective response rate was 51.4% and median duration of response was 19.4 months. In DESTINY-Lung01, objective response rate was 52.9% and median duration of response was 6.9 months. In DESTINY-CRC02, objective response rate was 46.9%, and duration of response was 5.5 months.
The prescribing information includes a Boxed Warning advising health professionals of the risk of interstitial lung disease and embryo-fetal toxicity.
This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. The application reviews are ongoing at the other regulatory agencies.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
Full prescribing information for these approvals can be found on the web at www.fda.gov/drugsatfda.
Health care professionals should report serious adverse events to www.fda.gov/medwatch.
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