Breast cancer is a prevalent cancer worldwide, necessitating effective treatment options. This paper aims to select successful breast cancer molecules based on specific criteria and investigate the regulatory challenges encountered in the approval pathway. The study focuses on currently used drugs in the targeted therapy category that have achieved blockbuster status or significant market value. Employing a qualitative research design, the study explores the timelines of approvals for breast cancer drugs by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The research reveals several regulatory challenges and proposes strategies to overcome them. Solutions include leveraging accelerated approval pathways with predefined surrogate endpoints, utilizing schemes such as the Prescription Drug User Fee Act , engaging Contract Research Organizations for multinational trials, and adopting modern software for enhanced data management. Significant differences in approval timelines between the FDA and EMA are identified, underscoring the necessity for harmonization in approval processes and decision opinion exchange between regulatory authorities. The findings provide valuable insights into future regulatory strategies aimed at addressing these challenges and improving the overall regulatory processes for breast cancer products. The improvement of patient outcomes and the global fight against breast cancer are both benefited by this study’s contribution to the development of breast cancer treatment.
Key words: Clinical trials, Breast Cancer, Regulations, Challenges, Targeted therapies
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