ENHERTU approved in the U.S. as the first HER2 directed for low metastatic breast cancer
Drug Approval

ENHERTU approved in the U.S. as the first HER2 directed for low metastatic breast cancer

Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy

  • By IPP Bureau | August 09, 2022

Daiichi Sankyo and AstraZeneca’s ENHERTU (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

The approval was granted under the FDA’s Real-Time Oncology Review (RTOR) program following the recent Priority Review and Breakthrough Therapy Designation of ENHERTU in the U.S. in this setting. The expanded approval for ENHERTU in the U.S. enables its use across a wide spectrum of HER2 expression, including patients with HER2 low disease.

The approval by the U.S. Food and Drug Administration (FDA) was based on positive results from the DESTINY-Breast04 phase 3 trial of previously treated patients with HER2 low metastatic breast cancer. In the trial, ENHERTU demonstrated a 49% reduction in the risk of disease progression or death versus physician’s choice of chemotherapy in patients with HER2 low metastatic breast cancer with hormone receptor (HR) positive disease (hazard ratio [HR] = 0.51; 95% confidence interval [CI]: 0.40-0.64; p<0.0001).

“Approximately half of all patients with breast cancer have tumors that are HER2 low, which have previously been classified as HER2 negative and have not had effective treatment options with HER2 targeted medicines,” said Shanu Modi, MD, medical oncologist, Memorial Sloan Kettering Cancer Center and principal investigator for the trial. “Based on the promising results of the DESTINY-Breast04 trial, clinicians are starting to differentiate levels of HER2 expression and redefine how metastatic breast cancer is classified with a distinct HER2 low patient population that may be eligible for trastuzumab deruxtecan.”

ENHERTU is approved with Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and Embryo-Fetal toxicity.

“Today’s FDA approval marks a monumental moment in breast cancer treatment as ENHERTU is the firstever HER2 directed medicine to be approved for the treatment of patients with HER2 low metastatic breast cancer,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc.

“With the groundbreaking survival benefit seen in the DESTINY-Breast04 trial, this milestone confirms the importance of targeting lower levels of HER2 expression in the treatment of metastatic breast cancer and we are thrilled that we can now offer ENHERTU to even more patients.”

“The rapid approval of ENHERTU in HER2 low metastatic breast cancer by the FDA underscores the urgency to bring this transformational medicine to patients as quickly as possible,” said Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca. “Patients with HER2 low tumors, who are identified through existing HER2 testing methods, will now have the opportunity to be treated based upon their HER2 status.”

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