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The Next Phase In Oncology: FDA’s Pazdur Has New Vision For Drug Development

Executive Summary

FDA’s top cancer drug reviewer has taken to the podium to paint a picture of the next phase in cancer drug development, which includes new business models, a return to single-arm trials and a new emphasis on safety.

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Tissue-Agnostic Approach To Cancer Drug Development Takes A Hit

Roche's VE-BASKET trial based treatment on biomarkers instead of the tissue of origin, but it ended up reinforcing the importance of conventional tumor histology in drug development as a complement to new molecularly targeted approaches. Now, eyes are on Novartis' ambitious SIGNATURE program to confirm the signal-finding potential of the basket trial approach.

In Brief: Bristol’s Nivolumab Shows Survival, Boehringer Gains A Breakthrough & Sentinel Takes On Flu Vaccines, Plus CHMP Opinions

Bristol’s early stop of a nivolumab trial in melanoma offers the first late-stage, randomized survival data for the PD-1 class; Boehringer’s Pradaxa antidote is on the breakthrough track; CHMP clears Bristol’s daclatasvir ahead of FDA; and FDA concludes flu vaccines aren’t linked to seizures.

FDA Often Looks Outside The Application, Review Documents Show

A look back at drug reviews in the past year illustrates the many ways FDA takes external factors into consideration when reviewing an application – from guiding trials to look for certain class safety signals to finding support for a particular endpoint.

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