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Limited Direct Comparison of Me-Too Oncology Drugs with First-in-Class Agents: Clinical Implications and Regulatory Considerations
Posted inClinical Updates Wellness & Lifestyle

Limited Direct Comparison of Me-Too Oncology Drugs with First-in-Class Agents: Clinical Implications and Regulatory Considerations

Posted by By MedXY 07/31/2025
Analysis of FDA approvals from 2009–2020 reveals only 29% of next-in-class oncology drugs underwent head-to-head RCTs against originals, with just 22% showing survival benefits, highlighting a need for incentivized comparative trials.
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