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EMA Initiates Review of Novel Lung and Breast Cancer Treatment Datopotamab Deruxtecan

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The European Medicines Agency (EMA) has begun the rigorous review of marketing authorization applications from AstraZeneca and Daiichi Sankyo for datopotamab deruxtecan (Dato-DXd), a novel therapeutic agent targeting two challenging and prevalent global lung and breast cancer. Specifically, these dual applications are focused on offering a groundbreaking treatment solution for adult patients suffering from advanced nonsquamous non-small cell lung cancer (NSCLC) and those diagnosed with hormone receptor (HR)-positive, HER2-negative lung cancer. This strategic move by AstraZeneca and Daiichi Sankyo is poised to significantly revolutionize the current landscape of cancer therapy, introducing a novel mechanism of action against these formidable diseases.

The introduction of datopotamab deruxtecan into the cancer treatment arena is especially noteworthy given the dire need for more effective therapeutic options for patients battling advanced stages of NSCLC and HR-positive, HER2-negative breast cancer. Both conditions represent a considerable burden on the healthcare system and pose significant challenges in terms of patient management and outcomes. The current standard of care, which often relies on conventional chemotherapy, leaves much to be desired in terms of efficacy and patient quality of life, underscoring the critical importance of innovative treatments like datopotamab deruxtecan that promise enhanced efficacy and potentially improved side effect profiles.

A Promising TROP2-Targeted Therapy for Lung and Breast Cancer Under EMA Review

By targeting the TROP2 receptor, a protein frequently overexpressed in many solid tumors, including NSCLC and HR-positive, HER2-negative breast cancers, datopotamab deruxtecan represents a novel approach in the fight against cancer. This targeted therapy is designed to deliver potent chemotherapy directly to cancer cells while sparing healthy tissues, thereby offering the potential for significant improvements in progression-free survival and overall patient outcomes compared to traditional chemotherapy regimens.

The EMA’s decision to initiate the review of these applications marks a crucial step forward in the journey to bring datopotamab deruxtecan to patients in need across Europe. It reflects the agency’s commitment to facilitating access to new and innovative therapies that can make a real difference in the lives of those affected by cancer. As the scientific review process unfolds, the oncology community eagerly anticipates the potential impact of datopotamab deruxtecan on the standard of care for advanced nonsquamous NSCLC and HR-positive, HER2-negative breast cancer, two of the most common and challenging cancers to treat.

These applications, grounded in the outcomes of the TROPION-Lung01 and TROPION-Breast01 Phase III trials, showcased datopotamab deruxtecan’s capability to significantly enhance progression-free survival compared to standard chemotherapy treatments. This innovative therapy, a TROP2-directed DXd antibody-drug conjugate (ADC), has been jointly developed by AstraZeneca and Daiichi Sankyo, demonstrating their commitment to transforming cancer care.

Breast Cancer

Aiming to Transform Lung and Breast Cancer Care, Awaiting EMA Approval

Susan Galbraith, AstraZeneca’s Executive Vice President of Oncology R&D, highlighted the potential of datopotamab deruxtecan to redefine treatment expectations for lung and breast cancer, aiming to improve upon and eventually replace traditional chemotherapy. Similarly, Ken Takeshita, MD, Global Head of R&D at Daiichi Sankyo, emphasized the importance of EMA validation as a crucial step towards making this therapy available to patients in Europe, further indicating ongoing regulatory efforts in the US and globally.

The demand for effective treatments is underscored by the prevalence of lung and breast cancer in Europe, with nearly 500,000 lung cancer cases and over 500,000 breast cancer cases diagnosed in 2022 alone. NSCLC, accounting for about 80% of lung cancer cases, and HR-positive, HER2-negative breast cancer, representing the most common breast cancer subtype, highlight the urgent need for new therapeutic options.

Datopotamab deruxtecan’s development and potential approval represent a significant step forward in meeting these needs, offering hope to patients who have limited treatment options. The TROPION program, encompassing more than 14 trials across multiple cancer types, illustrates the broad potential of this therapy to impact cancer care significantly.

 

Resource: Astrazeneca, March 04, 2024

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