‘Regulatory Flexibility’ For Innovent/Lilly’s Sintilimab Not Warranted, US FDA Says
Advisory committee will vote on whether an additional trial demonstrating applicability of results from the Phase III study in China is needed prior to approval; agency says PD-1 inhibitor does not fulfill an unmet need in the US for non-small cell lung cancer.
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Clinical Trial Diversity Action Plans Required Under US Funding Bill
Omnibus legislation requires FDA to issue guidance documents and hold public workshops on clinical trial diversity, but it does not give the agency authority to mandate postmarketing studies if a preapproval trial falls short of demographic diversity goals.
US FDA’s Project Site Selector Kicks Off With A Look At Why Cancer Trials Go Overseas
Speed, logistics and global regulatory demands are all reasons why sponsors increasingly look outside the US to enroll cancer trials, industry reps say during the inaugural event for the Oncology Center of Excellence's new initiative; OCE director Pazdur says multiregional trials can help provide patients access to important new drugs quickly in the US or worldwide.
Foreign Data: Sintilimab’s Development Shows What Not To Do When Pursuing US Approval
The FDA’s concerns about conduct of ORIENT-11 trial include adequacy of informed consent, uncertainty about confidence in data generated in China, and failure of development partners Innovent and Eli Lilly to consult the US regulator about the study’s design.