BioCentury
ARTICLE | Politics & Policy

CFDA releases submission guidelines for anti-PD-1, PD-L1 mAbs

February 9, 2018 11:08 PM UTC

China FDA's Center for Drug Evaluation (CDE) said single-arm trials with objective response rate (ORR) as the primary endpoint are sufficient for sponsors wanting to submit rolling NDAs for checkpoint inhibitors. The country has yet to approve any anti-PD-1 or PD-L1 mAbs.

In guidance posted Thursday, the agency also said companies will be required to have full safety data and the results of at least two independent assessments. During NDA review, companies will need to submit six-month follow-up data that demonstrate duration of response. Before the NDA is approved, all efficacy and safety data will need to be filed...