FDA Approves Fam-Trastuzumab Deruxtecan-nxki for Patients With HER2–Positive Breast Cancer
On May 4, 2022, the US Food and Drug Administration (FDA) granted approval to fam-trastuzumab deruxtecan-nxki for the treatment of adult patients with unresectable or metastatic HER2–positive breast cancer, who have previously received an anti-HER2-based regimen in the metastatic, neoadjuvant, or adjuvant setting and have experienced disease recurrence during or within 6 months of completing therapy.
This agent received accelerated approval for adult patients with unresectable or metastatic HER2–positive breast cancer who have received 2 or more previous anti-HER2-based therapies in the metastatic setting in December 2019.
This approval was granted based on results from the DESTINY-Breast03 phase 3 trial, which showed that fam-trastuzumab deruxtecan-nxki reduced the risk of disease progression or death by 72% when compared to trastuzumab emtansine in patients with HER2–positive unresectable and/or metastatic breast cancer who had previously been treated with trastuzumab or a taxane.
The safety profile of the agent was comparable to other trials. The most common adverse reactions of patients receiving fam-trastuzumab deruxtecan-nxki were nausea, fatigue, vomiting, alopecia, constipation, anemia, and musculoskeletal pain. Less than 1% of patients experienced serious adverse reactions, which included vomiting, interstitial lung disease, pneumonia, pyrexia, and urinary tract infection. There were no new safety concerns in this trial, or grade 4 or 5 treatment-related interstitial lung disease events identified.
Data from this trial has also added fam-trastuzumab deruxtecan-nxki to the National Comprehensive Cancer Network (NCCN) Clinical Practical Guidelines in Oncology as the Category 1 preferred regimen for second-line therapy in recurrent unresectable stage IV HER2–positive disease.
Sources:
FDA grants regular approval to fam-trastuzumab deruxtecan-nxki for breast cancer. News release. FDA; May 4, 2022.
Enhertu (fam-trastuzumab deruxtecan-nxki) approved in the US for patients with HER2-positive metastatic breast cancer treated with a prior anti-HER2-based regimen. News release. AstraZeneca; May 5, 2022.
