AstraZeneca’s Enhertu gets EU nod for breast cancer treatment

AstraZeneca PLC (LSE:LON:AZN), a pharmaceutical giant with a market capitalization of $224 billion and an impressive gross profit margin of 82%, announced today that its drug Enhertu has been approved by the European Union for the treatment of a specific type of metastatic breast cancer. According to InvestingPro analysis, AstraZeneca (NASDAQ:AZN) is currently trading above its Fair Value, reflecting strong market confidence in its product pipeline and growth potential. This approval enables the use of Enhertu as a monotherapy for adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have previously undergone at least one endocrine therapy.

The European Commission’s decision is based on the positive outcomes of the DESTINY-Breast06 Phase III trial, which demonstrated that Enhertu significantly improved median progression-free survival compared to chemotherapy, extending it to over a year. The results of this trial were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine.

This latest approval positions Enhertu earlier in the treatment paradigm for HR-positive, HER2-low breast cancer and expands the eligible patient population to include those with HER2-ultralow disease. Enhertu is a HER2-directed antibody drug conjugate (ADC) developed in collaboration with Daiichi Sankyo.

Giuseppe Curigliano, MD, PhD, the principal investigator for the DESTINY-Breast06 trial, highlighted the significance of this approval, noting the superior performance of Enhertu over chemotherapy in the trial.

Dave Fredrickson of AstraZeneca emphasized the importance of testing for any level of HER2 expression to identify candidates for Enhertu treatment. Ken Keller of Daiichi Sankyo echoed this sentiment, stating that Enhertu is evolving breast cancer treatment by becoming the first HER2-directed medicine approved in the EU for this patient group following endocrine therapy.

The safety profile of Enhertu in the DESTINY-Breast06 trial aligns with previous clinical trials, with no new safety concerns identified. Enhertu is also approved in the US and other countries for similar indications, and regulatory reviews are ongoing in Japan and several other countries. As a prominent player in the pharmaceuticals industry, AstraZeneca has maintained strong financial performance with 18% revenue growth over the last twelve months. InvestingPro subscribers can access 8 additional key insights about AstraZeneca’s market position and growth prospects through the comprehensive Pro Research Report.

Financially, AstraZeneca owes Daiichi Sankyo a milestone payment of $125 million following this EU approval, which will be amortized through the profit and loss statement. Sales of Enhertu in most EU territories are recognized by Daiichi Sankyo, while AstraZeneca reports its share of gross profit margin from these sales as alliance revenue. The company’s strong financial health is evidenced by its 33-year track record of consistent dividend payments and robust cash flows. For deeper insights into AstraZeneca’s financial metrics and future growth potential, investors can access detailed analysis and valuation models through InvestingPro’s exclusive research tools.

The article is based on information contained in an SEC filing by AstraZeneca.

In other recent news, AstraZeneca has achieved notable milestones across its drug portfolio. The U.S. Food and Drug Administration (FDA) has approved AstraZeneca’s Imfinzi for use in treating muscle-invasive bladder cancer (MIBC), marking it as the first immunotherapy approved for this condition. The approval follows the NIAGARA Phase III trial, which demonstrated a 32% reduction in disease progression risk and a 25% decrease in death risk when Imfinzi was used in combination with chemotherapy. In addition, AstraZeneca’s experimental cholesterol drug AZD0780 showed promising results in a Phase IIb clinical trial by significantly reducing LDL-C levels in patients. The trial results were presented at a major cardiology conference, highlighting AZD0780’s potential as a convenient oral therapy for cholesterol management.

Moreover, AstraZeneca’s Calquence received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for treating mantle cell lymphoma (MCL) in the European Union. This recommendation is based on Phase III trial results showing improved progression-free survival for patients using Calquence in combination with other therapies. Additionally, AstraZeneca has disclosed its total number of voting rights as of March 31, 2025, in compliance with regulatory requirements, with a total of 1,550,623,487 voting rights available. These recent developments underscore AstraZeneca’s ongoing efforts to expand treatment options across various therapeutic areas.

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