The US FDA Issued Complete Response Letter to Hutchmed’s Surufatinib for the Treatment of Advanced Neuroendocrine Tumors
Shots:
- The FDA has rejected Hutchmed’s application for surufatinib in pancreatic and extra-pancreatic neuroendocrine tumors (NETs) with a CRL which indicated that MRCT is required for approval in the US
- The MRCT should include subjects more representative of the US patient population and aligned to current US medical practice. Hutchmed is now working with the FDA to evaluate next steps
- The FDA determined that two P-III SANET-p and SANET-ep studies conducted in China and P-I bridging study in the US did not support the approval of the therapy in the US
Ref: Globenewswire | Image: Hutchmed
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