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A Cancer Drug Is Approved by Biomarker, Not Organ
From How Cancer Treatment Became Personal: From Chemotherapy to Precision Immunotherapy
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Regulatory
A Cancer Drug Is Approved by Biomarker, Not Organ
Pembrolizumab received the first tumour-agnostic approval, treating eligible cancers according to a shared molecular feature wherever they began.
Cancer classification had traditionally started with anatomy, such as lung, breast or colon. The approval made a molecular property sufficient to define treatment eligibility across different organs, a major step toward precision oncology. The biomarker still identified only a minority of tumours and did not guarantee response.
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