AstraZeneca has begun selling a Chinese-developed lung cancer drug in the U.S. that some American patients had been flying to China to buy.
The British-Swedish drugmaker said Oct. 22 that sunvozertinib, sold under the brand name Zegfrovy, is now available in the U.S., more than 15 months after the FDA approved it.
Developed by Shanghai-based Dizal Pharmaceutical, the once-daily pill is approved for adults with advanced non-small cell lung cancer whose tumors carry a mutation known as an EGFR exon 20 insertion and whose disease has progressed on or after platinum-based chemotherapy.
China's National Medical Products Administration approved the drug in August 2023. The FDA granted it accelerated approval on July 2, 2025, based on a trial in which 46% of 85 patients responded to treatment, and continued approval may depend on further trials confirming its benefit.
Max Doppelt, whose mother has lung cancer, flew to Shanghai and came home with 26 boxes of the drug, the South China Morning Post reported. He said he knows of at least 30 other Americans who have made the same trip.
"I'm very thankful to all the development that companies in China have done because it saved my mum's life," said Doppelt, who runs a company that helps cancer patients find clinical trials.
He said he decided to make the trip after his mother's cancer spread to her brain, where she had about 10 tumors.
He called for FDA reforms, including greater transparency around clinical trials, and said the U.S. could learn from China, where "there are dozens of cellular therapy trials that are spun up all the time."
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A man holds a pill in his palm. Illustration photo by Unsplash/Towfiqu barbhuiya |
His mother, Debbie Doppelt, a jeweler, has done well on the drug, according to a KFF Health News report published by The Washington Post on Oct. 20. About 19 months after she started the drug, her cancer was still largely held in check, helped by a few radiation treatments and dose adjustments, the report said.
A 70-year-old woman Max Doppelt had helped got a six-month supply of the drug from China this year, only to learn after three months that it was not working, according to the report.
Obtaining medication abroad for personal use is sometimes legal, but the FDA "cautions patients about potential safety and quality risks associated with treatments outside our regulatory system," a Department of Health and Human Services spokesperson told the outlet.
AstraZeneca agreed in July to license worldwide rights to the drug from Dizal, paying $600 million upfront, with up to $900 million more tied to development, regulatory and sales milestones, plus tiered royalties on sales.
An AstraZeneca spokesperson told the South China Morning Post that the deal was completed only on Sept. 1 and that the company had been working to bring the drug to U.S. patients as quickly as possible.
China's share of early-stage drug development programs worldwide rose from 8% in 2015 to 32% in 2024, while the U.S. share fell from 48% to 37%, according to a study published in the Journal of the American Medical Association in March.