AstraZeneca Withdraws Bladder-Cancer Indication for Imfinzi in U.S.
22 Februar 2021 - 8:50AM
Dow Jones News
By Cecilia Butini
AstraZeneca PLC said Monday that it has voluntarily withdrawn
the bladder-cancer indication on its Imfinzi monoclonal-antibody
drug in the U.S.
The British pharmaceutical giant said the decision was made in
consultation with the U.S. Food and Drug Administration after a
phase-3 study of the drug didn't meet its primary endpoint in 2020,
preventing continued approval from the agency.
The agency had granted Imfinzi accelerated approval for bladder
cancer in the U.S. in 2017.
The company added that the withdrawal doesn't affect other
approved indications for Imfinzi within or outside the U.S., and
that it doesn't affect the bladder-cancer indication outside the
U.S.
Write to Cecilia Butini at cecilia.butini@wsj.com
(END) Dow Jones Newswires
February 22, 2021 02:35 ET (07:35 GMT)
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