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AstraZeneca withdraws EU application for lung cancer drug

EditorAhmed Abdulazez Abdulkadir
Published 26/12/2024, 16:28
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AstraZeneca PLC (LSE:LON:AZN), a pharmaceutical giant with a market capitalization of $203 billion and impressive gross profit margins of 83%, and its partner Daiichi Sankyo have decided to withdraw their application for marketing authorization in the European Union for their drug datopotamab deruxtecan, intended to treat a form of lung cancer.

According to InvestingPro analysis, AstraZeneca (NASDAQ:AZN) maintains a strong financial health score of "GREAT," reflecting its robust market position. This decision, announced today, came after the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) provided feedback on the application, which was based on the TROPION-Lung01 Phase III trial.

The drug, a TROP2-directed DXd antibody drug conjugate (ADC), was being considered for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC). Despite the withdrawal, AstraZeneca and Daiichi Sankyo remain committed to making datopotamab deruxtecan available to lung cancer patients in the EU who might benefit from it. They continue to pursue a comprehensive clinical development program, which includes seven pivotal trials in various lung cancer settings.

While the application for datopotamab deruxtecan in NSCLC has been withdrawn, another application by AstraZeneca and Daiichi Sankyo for the drug's use in hormone receptor (HR)-positive, HER2-negative metastatic breast cancer is still under review by the EMA.

With annual revenue of $51.2 billion and consistent growth, AstraZeneca continues to demonstrate strong commercial execution. InvestingPro data shows 4 analysts have recently revised their earnings upwards for the upcoming period.

In recent clinical trial updates, datopotamab deruxtecan showed a statistically significant improvement in progression-free survival over the chemotherapy drug docetaxel. Detailed results from the TROPION-Lung01 trial were shared at the European Society for Medical (TASE:PMCN) Oncology 2023 Congress and the IASLC 2024 World Conference on Lung Cancer, with simultaneous publication in the Journal of Clinical Oncology in September 2024.

AstraZeneca, a global biopharmaceutical company, is engaged in developing a broad portfolio of cancer treatments and is actively working with Daiichi Sankyo to develop and commercialize several ADCs, including datopotamab deruxtecan.

The company's efforts in oncology focus on delivering life-changing medicines to patients, with the ultimate ambition of eliminating cancer as a cause of death.

InvestingPro analysis suggests the stock is currently undervalued, with strong fundamentals supported by 32 consecutive years of dividend payments and robust cash flows. For detailed insights and access to the comprehensive Pro Research Report covering AstraZeneca's full potential, investors can explore InvestingPro's advanced analytics platform.

The information in this article is based on a press release statement from AstraZeneca.

In other recent news, AstraZeneca has seen several significant developments. The pharmaceutical giant's oncology medication, Tagrisso, received approval from the European Union for the treatment of a specific type of lung cancer. This approval was based on the outcomes of the LAURA Phase III clinical trial, which demonstrated the drug's effectiveness in prolonging median progression-free survival.

In addition, AstraZeneca announced the appointment of Rene Haas and Birgit Conix as Non-Executive Directors, a move that forms part of the company's ongoing board refreshment process. AstraZeneca also formed a multi-year collaboration with Tracer Biotechnologies, focusing on the use of Tracer's advanced circulating tumor DNA (ctDNA) monitoring technology in clinical trials.

Furthermore, the U.S. Food and Drug Administration (FDA) approved AstraZeneca's Imfinzi for the treatment of adult patients with limited-stage small cell lung cancer. This approval was granted based on the results from the ADRIATIC Phase III trial.

Lastly, AstraZeneca announced the appointment of Iskra Reic as its new Executive Vice President for the International division. Reic, who has been with AstraZeneca since 2001, will now oversee strategy and drive sustainable growth across a diverse region.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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