Enhertu Received Regular FDA Approval for Patients with Unresectable or Metastatic Breast Cancer

JHOP - June 2022 Vol 12, No 3 - FDA Oncology Update, Breast Cancer
Download PDF

On May 4, 2022, the FDA granted a regular full approval for fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo) for adults with unresectable or metastatic HER2-positive breast cancer who had previously received an anti-HER2 regimen in the metastatic or the neoadjuvant or adjuvant setting whose disease recurred during or within 6 months of completing therapy, based on the confirmatory DESTINY-Breast03 clinical trial.

“Enhertu has demonstrated significant progression-free survival in the earlier metastatic setting, potentially establishing it as a new standard of care in previously treated patients with HER2-positive metastatic breast cancer. Today’s approval is an important milestone for the clinical community as we will now be able to offer Enhertu to these patients earlier in their treatment,” said Erika Hamilton, MD, Director of the Breast Cancer and Gynecological Cancer Research Program, Sarah Cannon Research Institute, Nashville, TN, in a press release.

This regular approval was based on the results of the confirmatory clinical trial DESTINY-Breast03 conducted after the December 2019 FDA accelerated approval for fam-trastuzumab deruxtecan for adults with unresectable or metastatic HER2-positive breast cancer who have received ≥2 anti-HER2 regimens in the metastatic setting.

The DESTINY-Breast03 study was a multicenter, open-label, randomized clinical trial of 524 patients with HER2-positive, unresectable, and/or metastatic breast cancer who had received trastuzumab and taxane therapy for metastatic disease or whose disease recurred during or within 6 months of completing neoadjuvant or adjuvant therapy. Patients were randomized (1:1) to intravenous fam-trastuzumab deruxtecan or to ado-trastuzumab emtansine every 3 weeks, until disease progression or unacceptable adverse events.

The main efficacy outcome measure was progression-free survival (PFS). Key secondary end points were overall survival (OS) and confirmed objective response rate (ORR). The median PFS was not reached (95% confidence interval [CI], 18.5-not estimable) in the fam-trastuzumab deruxtecan arm and was 6.8 months (95% CI, 5.6-8.2) in the ado-trastuzumab emtansine arm. The hazard ratio was 0.28 (95% CI, 0.22-0.37; P <.0001). At the time of the PFS analysis, 16% of patients had died and the OS was immature. The ORR was 82.7% (95% CI, 77.4-87.2) and 36.1% (95% CI, 30.0-42.5), respectively.

The most common (incidence >30%) adverse reactions with fam-trastuzumab deruxtecan were nausea, fatigue, vomiting, alopecia, constipation, anemia, and musculoskeletal pain. Serious adverse reactions in >1% of patients with this drug were vomiting, interstitial lung disease, pneumonia, pyrexia, and urinary tract infection. The prescribing information of fam-trastuzumab deruxtecan includes a warning about the risk for interstitial lung disease and embryo-fetal toxicity.

Related Items
FDA-Approved Nirogacestat Demonstrates Improved Patient Outcomes in Desmoid Tumor Management
Web Exclusives published on February 12, 2024 in FDA Oncology Update
Iwilfin FDA Approved for Adults and Pediatric Patients with High-Risk Neuroblastoma
Web Exclusives published on January 17, 2024 in FDA Oncology Update
Welireg Now FDA Approved for Patients with Advanced Renal Cell Carcinoma
Web Exclusives published on January 17, 2024 in FDA Oncology Update
The Pharmacist and Patients With HER2-Positive or HER2-Low Metastatic Breast Cancer: Navigating the Treatment Landscape
The Pharmacist and Patients With HER2-Positive or HER2-Low Metastatic Breast Cancer: Navigating the Treatment Landscape published on January 11, 2024 in Breast Cancer
Ovarian Function Suppression in Premenopausal Women with HR+ Breast Cancer
Emily M. Beard, RN, BSN, OCN, CBCN, Abbey J. Kaler, MS, APRN, FNP-C, Mohammed A. Jaloudi, MD
Best Practices in Ovarian Function Suppression in Breast Cancer published on December 21, 2023 in Breast Cancer
Keytruda Plus Chemotherapy Receives New FDA Approvals for Advanced Biliary Tract Cancer and 2 Forms of Advanced Gastroesophageal Junction Adenocarcinoma
Web Exclusives published on December 19, 2023 in FDA Oncology Update
FDA Approved Loqtorzi, a PD-1 Inhibitor, for the Treatment of Adults With Metastatic or Recurrent Nasopharyngeal Carcinoma
Web Exclusives published on December 18, 2023 in FDA Oncology Update
Tibsovo FDA Approved for Patients With Relapsed Myelodysplastic Syndromes and IDH1 Mutation
Web Exclusives published on December 18, 2023 in FDA Oncology Update
Fruzaqla FDA Approved for Refractory Metastatic Colorectal Cancer
JHOP - December 2023 Vol 13, No 6 published on December 6, 2023 in FDA Oncology Update
Rozlytrek Now Approved for Pediatric Patients Older Than 1 Month With Solid Tumors and NTRK Gene Fusion and in New Oral Pellet Form
JHOP - December 2023 Vol 13, No 6 published on December 6, 2023 in FDA Oncology Update
© Amplity Health. All rights reserved.

Subscribe Today!

To sign up for our newsletter or print publications, please enter your contact information below.

I'd like to receive: