FDA Clarifies its Policies on China-Only Data
May 4, 2022
In its decision to reject Hutchmed’s NDA for its cancer drug surufatinib, the FDA has reiterated its stance on China-only trials. In recent years, the agency has made a point that trials must include data from multiple nations, with particular emphasis on trials only conducted in China. However, this decision does not imply a blanket rejection of drugs primarily developed in china.
According to Amber Tong of Endpoints News, ”On the heels of Hutchmed’s disclosure, Coherus and Junshi Biosciences revealed that they, too, have received CRL for their PD-1, toripalimab — except that the reason purportedly has nothing to do with clinical data. Coherus and Junshi said the CRL simply requests ‘a quality process change,’ which they believe is ‘readily addressable.’ Once they refile a BLA, the FDA also noted that the review will take six months because the pandemic-related travel restrictions have hindered on-site inspections.”
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(Source: Endpoints News, May 2nd, 2022)