US FDA Still Seeking Sponsor Cooperation For Oncology Label Updates
Oncology Center of Excellence is reviewing a research report on fluorouracil, and will next look to update cisplatin's label, but eventually must convince the reference product sponsor to submit the changes.
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Revealing that the pegylated IL-10 therapy acquired in the Armo buyout two years ago has failed a pair of Phase II NSCLC trials, Lilly said it plans no further studies with the drug. Trulicity and Taltz led Lilly’s continuing growth story.
Under the Oncology Center of Excellence’s Project Renewal, agency has contracted with consulting firm Deloitte to establish subject matter expert research teams that will review published literature on off-patent drugs and suggest labeling updates.
Agency has targeted 40 older generic chemotherapeutics for revised labeling; FDA will develop the new labeling, which will include currently accepted uses, but needs the cooperation of reference product holders who would actually have to submit the supplement.