Pazdur on the challenge of approving drugs for small indications

ODAC recommends approval for tazemetostat in rare sarcoma, sNDAs for Lynparza, Keytruda

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The FDA Oncologic Drugs Advisory Committee in a session Dec. 17 and 18 considered three applications that were arranged thematically, to show how the agency is approaching indications where the number of patients is small and the disease catastrophic.

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Paul Goldberg
Editor & Publisher
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