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Erleada Clinical Study Report Is First Release In Drug Review Transparency Pilot

 
• By Bridget Silverman

US FDA publishes 1,000+ page CSR for J&J's prostate cancer drug, and eight more products will follow. But how useful will the extra information be?

bundles bales of paper documents. stacks packs pile on the desk in the office

The first clinical study report (CSR) made public by the US FDA, for Janssen Pharmaceutical Cos.'s prostate cancer drug Erleada, shows how dramatically the sheer volume of drug review information could expand under the agency's new clinical data transparency initiative.

The CSR for Erleada (apalutamide) includes 1,062 pages of data summaries and protocol detail for the single pivotal trial supporting FDA's Feb. 14, 2018, approval of the androgen receptor inhibitor...

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