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ASCO 2023 | Navigating regulatory challenges in developing and approving therapies for rare lymphomas
Neha Mehta-Shah, MD, Washington University in St Louis, St Louis, MO, highlights the importance of strategic planning to address regulatory challenges in approving novel therapies for rare lymphomas. Dr Mehta-Shah discusses the case of romidepsin and its approval and subsequent withdrawal due to the Phase III study not meeting its primary endpoint. Dr Mehta-Shah emphasizes the need for international collaboration in conducting studies for rare diseases, especially considering the increasing cost of clinical research. This interview took place at the American Society of Clinical Oncology (ASCO) 2023 Annual Congress in Chicago, IL.
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