Enhertu Recommended for EU Approval as HER2 Targeted Therapy
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 22 2026
0mins
Source: Newsfilter
- Clinical Trial Results: In the DESTINY-PanTumor02 trial, Enhertu achieved a 51.4% objective response rate (ORR) in HER2 positive tumor patients, with a median duration of response of 14.2 months, indicating its potential to transform treatment for patients with limited options.
- Multiple Cancer Indications: Enhertu demonstrated ORRs of 52.9% and 46.9% in DESTINY-Lung01 and DESTINY-CRC02 trials respectively, highlighting its efficacy in non-small cell lung cancer and colorectal cancer, thereby broadening its therapeutic indications.
- Safety Profile: Among 267 patients, Enhertu's safety profile was consistent with previous trials, with the most common adverse events being neutropenia and anemia, each at 10.9%, indicating its acceptability and safety in clinical use.
- Market Outlook: The positive CHMP opinion paves the way for Enhertu's approval in the EU, potentially becoming the first treatment option for HER2 positive metastatic solid tumors, which is expected to significantly enhance Daiichi Sankyo and AstraZeneca's market share in oncology.
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Analyst Views on AZN
Wall Street analysts forecast AZN stock price to rise
14 Analyst Rating
13 Buy
0 Hold
1 Sell
Strong Buy
Current: 185.330
Low
157.61
Averages
213.64
High
252.18
Current: 185.330
Low
157.61
Averages
213.64
High
252.18
About AZN
AstraZeneca PLC is a United Kingdom-based science-led biopharmaceutical company. The Company focuses on the discovery, development, and commercialization of prescription medicines. The Company operates across therapy areas, including Oncology; Cardiovascular, Renal and Metabolism (CVRM); Respiratory and Immunology (R&I); Vaccines and Immune Therapies (V&I), and Rare Disease. In the Oncology area, its key products include Tagrisso, Imfinzi, Calquence, Lynparza, and Enhertu. The key products of CVRM area include Farxiga/Forxiga, Brilinta/Brilique, Crestor, and Lokelma. In the R&I area, the key products are Symbicort, Fasenra, Breztri/Trixeo, and Tezspire. In the V&I Therapies area, the products are Beyfortus and FluMist. The products in the Rare Disease area are Ultomiris, Soliris, Strensiq, and Koselugo. It has about 191 projects in its development pipeline, including 19 new molecular entities (NMEs) in the late-stage pipeline. The Company distributes its products in over 125 countries.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Significant Clinical Trial Results: The Phase 3 POTOMAC trial demonstrated that the IMFINZI plus BCG regimen resulted in a statistically significant 32% reduction in the risk of high-risk disease recurrence or death compared to BCG alone, thereby enhancing patient survival expectations.
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See More
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- Clinical Trial Results: The approval is based on the phase III POTOMAC trial, which demonstrated a 32% reduction in the risk of high-risk disease recurrence or death with the Imfinzi regimen compared to BCG induction and maintenance alone, highlighting its clinical efficacy.
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- Regulatory Dynamics: Despite the FDA's Oncologic Drugs Advisory Committee failing to reach a consensus in April 2026, AstraZeneca has submitted additional ctDNA clearance data to support the application, indicating the company's proactive approach to regulatory challenges and its commitment to bringing the drug to market swiftly.
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