On 2 May, the US Food and Drug Administration (FDA) rejected Hutchmed’s new drug application (NDA) for its lead candidate, Sulanda (surufatinib), for the treatment of advanced neuroendocrine tumours (NETs). Issues pertaining to trial populations were raised in a complete response letter (CRL) and GlobalData expects this case to have wide implications for the whole field of oncology therapeutics.

China-based HUTCHMED received approval for its multi-receptor tyrosine kinase inhibitor Sulanda in China for the treatment of pancreatic and extra-pancreatic NETs in June last year and December 2020, respectively. Following the submission to Chinese authorities, NDAs were also submitted to the FDA and European Medicines Agency (EMA). Two large Phase III studies formed the basis of these submissions, specifically the SANET-p and SANET-ep trials, both of which achieved their primary endpoint of improving progression-free survival (PFS) over placebo. As both of these trials were carried out in China, concerns about how well this data would translate to a Western population necessitated a bridging study. HUTCHMED went with open-label, Phase II trials as bridging studies, specifically the NCT04579679 trial in the EU and NCT02549937 trial in the US.

The FDA’s CRL cited inspection scheduling issues and the requirement of a multinational randomised trial with a more diverse population. It is likely that the rejection was also related to the lack of an active comparator, as in the US, several drugs are already approved and used as standard of care for the same patient populations. Eli Lilly and Innovent recently faced a similar setback when the FDA rejected their application for the marketing of Tyvyt (sintilimab) in non-small cell lung cancer based on data from Chinese populations. A precedent for FDA approval with China-only data does, however, exist; in November 2019, Beigene’s Brukinsa (zanubrutinib) received accelerated approval for relapsed/refractory mantle cell lymphoma based on the NCT03206970 Phase II trial, which took place exclusively in China.

GlobalData had projected Sulanda to reach $97m in US peak annual sales by 2030. This rejection by the FDA could mean a 3–5 year delay to marketing authorisation, or a lack of marketing authorisation altogether, should HUTCHMED decide that a new Phase III multinational trial is not worth the upside. The newfound FDA stringency concerning data from Asian populations will affect a multitude of late-stage pipeline drugs in oncology, and GlobalData expects the FDA to show leniency only in cancers of the highest unmet need. A large number of Chinese companies planned their strategy around a relatively easy US launch based on previous guidance by the FDA, and this news suggests that such a strategy should now be re-evaluated for future NDAs.

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