North American Enrollment in Clinical Trials: An Emerging Issue for Regulatory Approval
The FDA’s Oncologic Drug Advisory Committee faced uncertainty regarding the applicability of global trial data to the United States, exemplified by differing progression‑free survival outcomes for therapies such as glofitamab in multiple myeloma.
The abstract discusses the FDA’s Oncologic Drug Advisory Committee (ODAC) meetings in 2025 and 2026 and the challenges in assessing the applicability of international clinical trial data to the United States. It reviews data from several trials—such as the GLOFIT‑2 STARGLO study, DREAMM‑7 and DREAMM‑8—and highlights differences in median progression‑free survival (PFS) and overall survival (OS) between Asian and American patient populations. The committee’s votes (e.g., 8–1 against the applicability of STARGLO to the US and 5–3 against the risk‑benefit profile of DREAMM‑7) illustrate uncertainties that may affect regulatory approval and access to therapies like glofitamab plus gemcitabine‑oxaliplatin, rituximab plus gemcitabine‑oxaliplatin, and belantamab mafodotin.
Understanding enrollment disparities and regulatory assessment challenges is critical for ensuring that therapeutic advances proven in international trials are appropriately evaluated and made available to U.S. patients, affecting both clinical practice and health‑policy decisions.
Evidence level: Feltételezés / hírjelzés. Nincs önálló tudományos bizonyíték.
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