EU Approves Two Applications for Datopotamab Deruxtecan in Advanced Nonsquamous Non-Small Cell Lung Cancer and HR Positive, HER2 Negative Breast Cancer Patients
Tuesday, March 05, 2024
The European Medicines Agency (EMA) has given its validation to two marketing authorization applications (MAAs) submitted by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) for their innovative drug, datopotamab deruxtecan (Dato-DXd), targeting two different types of cancer. One MAA focuses on the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who require systemic therapy after prior treatment. The other MAA aims at treating adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy and have received at least one additional systemic therapy.
Datopotamab deruxtecan is a specialized TROP2 directed DXd antibody drug conjugate (ADC) developed through collaboration between Daiichi Sankyo and AstraZeneca.
This validation signifies the completion of the applications and initiates the scientific review process by the EMA’s Committee for Medicinal Products for Human Use. The submissions are supported by data from the pivotal TROPION-Lung01 and TROPION-Breast01 phase 3 trials, presented at two Presidential Symposia during the European Society for Medical Oncology (ESMO23) 2023 Congress.
Ken Takeshita, MD, Global Head of R&D at Daiichi Sankyo, expressed, “The EMA validation is an important milestone in making this TROP2 directed antibody drug conjugate available to eligible patients in Europe suffering from nonsquamous lung cancer and HR positive, HER2 negative breast cancer.” Susan Galbraith, MBBChir, PhD, Executive Vice President of Oncology R&D at AstraZeneca, added, “Our goal is for datopotamab deruxtecan to supersede conventional chemotherapy in treating multiple cancer types, and today’s validation of our applications for lung and breast cancers brings us closer to reshaping treatment paradigms for patients.”
Additional regulatory submissions for datopotamab deruxtecan in lung cancer and breast cancer are also in progress in the U.S. and globally.
TROPION-Lung01 is a global phase 3 trial comparing the efficacy and safety of datopotamab deruxtecan with docetaxel in patients with locally advanced or metastatic NSCLC, with or without actionable genomic alterations, who require systemic therapy post-prior treatment.
TROPION-Breast01 is another global phase 3 trial comparing datopotamab deruxtecan with investigator’s choice of single-agent chemotherapy in patients with unresectable or metastatic HR positive, HER2 negative breast cancer who have progressed on and are not suitable for endocrine therapy.
NSCLC accounts for about 80% of lung cancer cases, with nonsquamous histology representing about 70% of NSCLC cases. Despite advancements, chemotherapy remains a crucial treatment option for patients with advanced NSCLC.
HR positive, HER2 negative breast cancer is the most common subtype of breast cancer, with standard initial treatment involving endocrine therapy. However, many patients with advanced disease develop resistance, necessitating alternative treatment options.
Datopotamab deruxtecan is an investigational TROP2 directed ADC, designed to target cancer cells expressing TROP2. It combines a humanized anti-TROP2 IgG1 monoclonal antibody with topoisomerase I inhibitor payloads via cleavable linkers.
Daiichi Sankyo and AstraZeneca have partnered globally for the joint development and commercialization of datopotamab deruxtecan, with Daiichi Sankyo handling manufacturing and supply. This collaboration extends to other ADCs, aiming to bring innovative cancer therapies to patients worldwide.
Source: businesswire.com
