SPY393.89-3.03 -0.76%
DIA319.39+0.55 0.17%
IXIC11,264.45-270.83 -2.35%

U.S. FDA declines to approve Hutchmed's China-tested cancer drug

U.S. FDA declines to approve Hutchmed's China-tested cancer drug

reuters.com · 05/02/2022 06:06
U.S. FDA declines to approve Hutchmed's China-tested cancer drug

- The U.S. Food and Drug Administration has declined to approve a cancer drug developed by Hutchmed Ltd OO13.HK, the China-based drugmaker said on Monday, handing yet another blow to treatments tested mainly in China.

In its so-called Complete Response Letter to the company, the U.S. regulator said current data, based on two trials in China and one bridging study in the United States, does not support an approval in the U.S. at this time.


(Reporting by Mrinalika Roy in Bengaluru; Editing by Krishna Chandra Eluri)

((mrinalika.roy@thomsonreuters.com; within U.S. +1 646 223 8780, outside U.S. +91 806749 8325;))