FDA Approves AstraZeneca, Daiichi Sankyo's Enhertu For Certain Type Of Breast Cancer Patients

On Monday, the U.S. Food and Drug Administration (FDA) approved AstraZeneca plc and Daiichi Sankyo’s DSNKY DSKYF Enhertu (trastuzumab deruxtecan) for adult patients with breast cancer that has progressed on one or more endocrine therapies in the metastatic setting.

The FDA granted the approval after securing Priority Review and Breakthrough Therapy Designation. It was based on results from the DESTINY-Breast06 Phase 3 trial.

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In the trial, Enhertu showed a 36% reduction in the risk of disease progression or death versus chemotherapy in the overall trial population of patients with chemotherapy-naïve HER2-low or HER2-ultralow metastatic breast cancer.

A median progression-free survival (PFS) of 13.2 months was seen in patients randomized to Enhertu compared to 8.1 months in those randomized to chemotherapy.

The confirmed objective response rate (ORR) in the overall trial population was 62.6% for Enhertu versus 34.4% for chemotherapy.

In an exploratory analysis of patients with HER2-ultralow expression, results were seen to be consistent between patients with HER2-low expression and HER2-ultralow expression.

Following this approval for Enhertu in the U.S., AstraZeneca is due $175 million as a milestone payment to Daiichi Sankyo.

Daiichi Sankyo recognizes Enhertu sales in the U.S. AstraZeneca reports its share of gross profit margin from Enhertu sales in the U.S. as Alliance Revenue in the company’s financial statements.

Recently, the FDA approved AstraZeneca’s Datroway (datopotamab deruxtecan or Dato-DXd) for adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

Price Action: AstraZeneca stock is up 0.09% at $70.14 during the premarket session at last check Tuesday.

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