USA – The US Food and Drug Administration has rejected two proposed new cancer drugs developed in China, highlighting a tougher regulatory stance toward such drugs in the United States.
Hutchmed, one of the two companies based in Hong Kong, said the FDA denied approval of its new drug, surufatinib used to treat pancreatic and neuroendocrine tumors.
In China, the drug has been approved for use and is marketed under the brand name Sulanda. However, the FDA determined that two phase 3 trials in China and a small phase 1 bridging study in the United States were insufficient for approval in the United States.
The FDA also declined the other cancer drug, produced by California-based Coherus BioSciences and its Chinese partner Shanghai Junshi Biosciences, citing “quality processes.”
This is the second time the FDA has rejected a drug that was primarily tested in China, indicating that the US regulator may tighten its scrutiny of the approval process for such drugs.
In March, it declined to approve a lung cancer drug developed by Indiana-based Eli Lilly and Suzhou-based Innovent Biologics, citing concerns that a China-only trial would not be applicable to the “racial diversity” of the US population.
“We have nothing against drugs being developed in China,” said Richard Pazdur, the director of the FDA’s cancer-drugs division. “Our issue is, are those results generalizable to the US population?”
Coherus BioSciences Inc and its Chinese partner Shanghai Junshi Biosciences Co Ltd said the FDA indicated their China-only trial for toripalimab, a cancer drug, may be sufficient, but declined to approve it due to quality issues.
According to Coherus, the FDA indicated that the target disease, a type of nasopharyngeal carcinoma with no approved treatment options in the United States, warrants flexibility in terms of the sufficiency of single-country clinical data on the drug.
The FDA raised concerns about facility inspections for both the Hutchmed and Coherus/Shanghai Junshi treatments due to delayed travel during the COVID-19 pandemic.
According to the companies, Coherus and Shanghai Junshi intend to resubmit their application for the drug’s approval by mid-summer 2022.
The FDA’s communication to Hutchmed, known as a Complete Response Letter, stated that its treatment for neuroendocrine tumors requires data from a study that is more representative of the patient population in the United States.
Hutchmed had conducted a “bridging study” in the United States, but the FDA recommended a multi-regional clinical trial, according to the company.
According to the FDA, there are at least 25 applications from China in drug development phases, either planned to be submitted or already under review, that are primarily or solely based on trial data from China, as of February.
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