Thoughts on Chinese CAR-T Ambitions after Lilly CRL and ODAC
On March 24, Lilly announced that the FDA has issued a CRL for Sintilimab + Pemetrexed and Platinum Chemotherapy in 1L non-squamous NSCLC. The CRL stated that the review cycle is complete, but the FDA is unable to approve the application in its current form, which is consistent with the outcome from February’s ODAC meeting which voted 14-1 against approving Lilly-Innovent’s PD-1 inhibitor (Lilly press release here). Recall that Lilly submitted an application to the FDA using only one pivotal trial conducted entirely in China. Despite the widespread lead-up and adcom media coverage, very little analysis or implications came through the lens of cell therapy, specifically CAR-T products. Since China is the #2 geography for conducting CAR-T clinical trials after the US, the Celltelligence team provides some hot takes on what the CRL outcome may mean for Chinese cell therapy companies with Western ambitions.
About The Author
The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.
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