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Foreign Data: Sintilimab’s Development Shows What Not To Do When Pursuing US Approval

 
• By Sue Sutter

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.

Tennis racket
Innovent and Lilly seemingly committed some unforced errors in how they conducted the ORIENT trial and brought the results to the US FDA. • Source: Alamy

Companies seeking to get an application through the US Food and Drug Administration based primarily on data from China or any other single country or region would be wise to heed the agency’s criticisms about the design and conduct of the Phase III trial for Innovent Biologics, Inc./Eli Lilly and Company’s PD-1 inhibitor sintilimab.

Looking beyond the primary question of whether the ORIENT-11 study results were generalizable to the US, the agency raised a host of concerns about the trial’s conduct and

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STARGLO Dulled: Genentech’s Columvi Data Not Generalizable To US Patients, FDA Panel Says

 
• By Sue Sutter

The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

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• By Derrick Gingery

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• By Cathy Kelly

MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.

More from North America

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

Biomarker Negativity At Issue In Pfizer Bid To Broaden Talzenna CRPC Claim

 
• By Bridget Silverman

The FDA questioned Pfizer’s reliance on a “large, incompletely defined” subgroup of castration-resistant prostate cancer patients without known HRR gene alterations in its review of the proposed expansion of Talzenna’s first-line indication for HRR-mutated CRPC to an all-comers population.

UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.