FDA Turns Down China-Produced Cancer Drug
May 3rd, 2022 // 1:32 pm @ jmpickett
After FDA rejected an immunotherapy drug produced by Eli Lilly and Innovent Biologics, FDA has done the same thing with another cancer drug made in China. It was submitted to the agency with pivotal trial data only from China, and FDA deemed that it wasn’t good enough.
Yesterday, Hutchmed told the media that FDA rejected its NDA for surufatinib in pancreatic and extra-pancreatic neuroendocrine tumors (NETs). FDA gave them a complete response letter that detailed why the drug was rejected.
The drug has already been approved by the Chinese government under the name Sulanda. But FDA found that two phase III trials only in China and a phase I bridging study in the United States weren’t good enough for an FDA approval.
This week, FDA asked Hutchmed to do a multiregional clinical trial with patients who more represent the people of the US and follow American medical practices.
Hutchmed said issues related to the global pandemic were one of the reasons the drug wasn’t approved. In March, the company noted that the agency has not done a cGMP inspection of its clinical and manufacturing facilities in China.
Hutchmed is working with the agency to figure out how to move forward with the rejected drug. The CEO of the company stated that Hutchmed is still confident that surufatinib has clinical value and will still bring the medication to the American market.
The oncology department at the US regulator adopted a familiar that it had with NDAs recently that only had clinical trial data from China. In March, FDA rejected the PD-1 inhibitor Tyvyt for non-small cell lung cancer. FDA criticized Eli Lilly and Innovent for relying on China-only phase III trials comparing the product to traditional chemotherapy.
For the surufatinib NDA, Hutchmed did two phase III clinical trials in China. Both trials were stopped when the product showed significant efficacy. In one study, the drug reduced the risk of disease progression/death by 50%.
