For Chinese companies bringing oncology drugs to the U.S., there’s been significant confusion recently. Much of it stems from the recent article published in The Lancet-Oncology, Importing Oncology Trials from China, a Bridge Over Troubled Waters, and the February 9 article from The Wall Street Journal titled FDA Raises Concerns About China-Developed Drugs.
From the titles, it’s clear that the FDA’s point of view has become more direct and negative about data from trials in China. However, the general consensus is that, even following the sintilimab situation, Chinese companies should still look to bring their trials, data, and drugs to the US.
For guidance, Chinese companies can refer to the NEJM The Wild West of Checkpoint Inhibitor Development article by Julia A. Beaver, M.D. and Richard Pazdur, M.D. In the article, the authors discuss how more than 2000 clinical trials are evaluating at least 33 anti–PD-1 or anti–PD-L1 antibodies and the rapid expansion of the checkpoint inhibitor class has largely been uncoordinated. The challenge with the FDA is across the entire class – not just the data from China. The authors encourage cooperation between sponsors and agencies, and Chinese companies should take this advice.
Also important is early interaction and communication, as outlined in How China Applicants Could Avoid the Sintilimab Scenario.
While pricing and competition were said to be outside the scope of the adcom, the panel meeting clearly had relevance beyond sintilimab. Other companies will have their work cut out persuading the FDA to be flexible in designing development paths but, with the agency apparently wanting to be flexible, early interaction holds the key.
For Chinese companies looking to bring oncology drugs to the US market, companies need to communicate early on with the FDA to establish how best to approach their particular situation and determine early on if their data is acceptable.
Medelis is here to help become your bridge between your trial and the FDA. Please feel free to contact us for a discussion about your study.
