The US Food and Drug Administration has expressed reservations about allowing drugmakers to roll out therapies developed in China, the Wall Street Journal reports.
It adds that the agency in 2019 approved BeiGene's Brukinsa (zanubrutinib) treatment for lymphoma, which was largely tested in China, and that Richard Pazdur, director of FDA's Oncology Center of Excellence, said at a conference that year that the agency would accept "quality" results from drug trials conducted in China.
But the Journal says that regulators now appear to have shifted away from that position, which could affect the plans of drugmakers like Eli Lilly, which hopes to offer an immunotherapy for lung cancer it developed in China.
Pazdur tells the Journal that one concern is that the drugs have not been tested in a US population. "We have nothing against drugs being developed in China," he adds there. "Our issue is, are those results generalizable to the US population?"
The Journal notes that agency advisors are to meet Thursday to discuss the therapy from Lilly and Innovent Biologics, its Chinese partner, and that that meeting could shed greater light on the agency's concerns.