How To Save A Drug After A Negative Panel Review? Narrow The Indication
Executive Summary
Novartis’ multiple myeloma drug Farydak and AstraZeneca’s ovarian cancer treatment Lynparza both fared poorly in their visits to the Oncologic Drugs Advisory Committee, yet they gained accelerated approval after the sponsors – at FDA’s urging – revised the indications to make the benefit/risk profile more attractive.
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