AstraZeneca and Daiichi Sankyo Launch Datroway for TNBC Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 22 2026
0mins
Source: NASDAQ.COM
- FDA Approval: AstraZeneca and Daiichi Sankyo announced that Datroway (datopotamab deruxtecan) has received FDA approval for the treatment of metastatic triple-negative breast cancer (TNBC), marking a significant advancement in this area and is expected to substantially improve patient survival rates.
- Clinical Trial Results: The TROPION Breast 02 trial, involving 644 TNBC patients who were not candidates for PD-1/PD-L1 inhibitor therapy, demonstrated a clinically meaningful 5-month improvement in median overall survival following treatment with Datroway, indicating its efficacy in extending patient survival.
- Significant Market Potential: With 345,000 new cases of TNBC diagnosed globally each year, accounting for 15% of all breast cancer cases, the launch of Datroway provides a new treatment option for this large patient population, potentially leading to substantial market revenue.
- Future Development Directions: In addition to TNBC, Datroway is also being evaluated for efficacy in non-small cell lung cancer and urothelial cancers, showcasing its broad potential indications and further solidifying AstraZeneca's strategic positioning in the oncology treatment landscape.
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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.
- Substantial Market Potential: It is estimated that over 31,000 high-risk NMIBC patients in the U.S. will be treated in 2024, and the approval of IMFINZI provides a new treatment option that could change the standard of care in this patient population.
- International Expansion Plans: AstraZeneca is pursuing regulatory submissions in the EU and Japan based on the POTOMAC trial results, indicating a strategic intent to expand its global market presence and further solidify its leadership in the biopharmaceutical sector.
See More
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- FDA Approval: AstraZeneca's Imfinzi (durvalumab) has received FDA approval for Bacillus Calmette-Guérin-naïve, high-risk non-muscle-invasive bladder cancer, marking a significant advancement in the company's oncology portfolio.
- 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.
- International Applications: AstraZeneca has submitted applications to regulators in the European Union and Japan based on the POTOMAC data, aiming to expand Imfinzi's market potential and enhance its competitive position globally.
- Financial Outlook: With the approval of Imfinzi, AstraZeneca is expected to see revenue growth in upcoming earnings reports, particularly in the oncology sector, further solidifying its attractiveness as a long-term investment.
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- Advisory Committee Vote: The FDA advisory committee voted 6-3 in April to reject the New Drug Application based on results from the pivotal SERENA-6 Phase 3 trial, reflecting concerns about the therapy's efficacy in clinical trials, which may lead to decreased investor confidence.
- Data Supplement Measures: AstraZeneca has taken steps to submit additional data, including long-term efficacy results of camizestrant, which will be presented at the upcoming ASCO meeting next month, aiming to enhance FDA recognition of its therapy and improve market competitiveness.
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See More
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- Clinical Trial Context: Camizestrant, an oral selective estrogen receptor degrader, is currently undergoing Phase III trials aimed at combining with CDK4/6 inhibitors, showing positive efficacy and safety results in the pivotal SERENA-6 trial.
- 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.
- International Approval Progress: Camizestrant has been approved in the UAE and Saudi Arabia, with regulatory applications under review in Japan and other countries, highlighting AstraZeneca's potential for global market expansion, especially in the breast cancer treatment sector.
See More
