F.D.A. Panel Rejects Lilly’s Cancer Drug Tested Only in China
The New York Times
The panel debated whether overseas trials could be applied to a more diverse U.S. population. The decision may affect other Chinese drug trials, and spotlights the high cost of immunotherapy.
An advisory committee to the Food and Drug Administration overwhelmingly voted on Thursday against recommending agency approval of a lung cancer drug that was tested only in China and sold there.
The drug, sintilimab, is a checkpoint inhibitor — a type of immunotherapy drug that unleashes the immune system to attack tumors. It was developed and tested in China by Innovent Biologics, which entered into an agreement with Eli Lilly that would have allowed Lilly to market it in the United States, if it were approved. It was to be used in combination with chemotherapy for patients with metastatic non-small-cell lung cancer.
The F.D.A. panel debated a longstanding issue: What standards should be used in approving drugs? Should a drug tested only in China or another country outside the United States be accepted without domestic trials?
Once confined to the five boroughs, the classic street snack has now gone fully nationwide.
But the report, on the experiences of 13 patients, found that the drug had no benefit for some people and that some who benefited said the improvement didn’t last.
Some older Americans have come to depend on virtual consultations with doctors, covered by Medicare. To keep that option in the future, Congress will have to act quickly.
Scientists say the snail darter, whose endangered species status delayed the building of a dam in Tennessee in the 1970s, is a genetic match of a different fish.
Modern religious leaders are experimenting with A.I. just as earlier generations examined radio, television and the internet.
More than 130 years after its inventor tried to introduce it in the U.S., whiskey made with a mold called koji is catching on in bars and stores.
Dr. Vivek Murthy’s report cites studies linking alcoholic beverages to at least seven malignancies, including breast cancer. But to add warning labels, Congress would have to act.
Not in this universe, a new study concludes.