FDA Declines to Approve Cancer Drugs Primarily Tested in China

The U.S. Food and Drug Administration (FDA) rejected two proposed cancer therapy medications on Monday.

The FDA sent two denial letters to biotechnology companies, Hutchmed Inc. and Coherus BioSciences Inc., on May 2.

Hutchmed manufactured a medication called surufatinib to treat pancreatic and extra-pancreatic neuroendocrine tumors.

According to a statement from the Hong Kong-based business, the company performed clinical trials in China and a supplemental study in the U.S. before submitting findings to the FDA to market the medicine in the U.S.

Hutchmed’s application was denied by the FDA, which stated in the Complete Response Letter (CRL) that approval of the medicine “will require a [multi-regional clinical trial] that includes subjects more representative of the U.S. patient population and aligned to current U.S. medical practice.”

Coherus BioSciences Inc. and Chinese partner Shanghai Junshi Biosciences Co. Ltd. said the FDA suggested that their China-only trial for cancer medication, toripalimab, may be sufficient but declined to approve it without a “quality process change.”

According to Coherus, the target disease, a type of nasopharyngeal cancer with no recognized therapies in the U.S., merits flexibility in terms of the sufficiency of single-country clinical data on the medicine.

Additionally, the FDA raised concerns about facility inspections for both the Hutchmed and Coherus/Shanghai Junshi facilities due to delayed travel during COVID-19.

According to the manufacturers, partners Coherus and Shanghai Junshi plan to re-submit their application by mid-summer.

The FDA has previously rejected treatments primarily tested in China. In March, it similarly turned down Eli Lilly and partner Innovent Biologics Inc’s lung cancer medication, which had only been tested in China.

The FDA’s Oncologic Drugs Advisory Committee said in a February hearing on Eli Lilly’s application that “the patient population in ORIENT-11, as a single country trial, does not reflect the diversity of the American population, with both known and unknown differences in intrinsic and extrinsic factors.”