Innovent Biologics, Inc./Eli Lilly and Company’s PD-1 inhibitor sintilimab fell hard at its US Food and Drug Administration advisory committee review for a host of reasons, not the least of which were the design, conduct and location of its Phase III trial.
Casualty Of Change? Innovent/Lilly’s Chinese PD-1 Inhibitor Sintilimab Falls Hard At US FDA Panel
Advisory committee says additional trials needed to demonstrate applicability of ORIENT-11 results to US population; in opting to seek approval only with Chinese data, Innovent said it relied on 2019 comments by FDA’s Richard Pazdur, but the oncology center head said therapeutic and societal changes have caused an evolution in the agency’s thinking.
More from US FDA Performance Tracker
• By
Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
• By
Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
• By
March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
• By
The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.
More from Regulatory Trackers
• By
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
• By
March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
• By
The European Medicines Agency is set to issue opinions this week on whether pan-EU marketing approval should be granted to a number of new products.