|
 Imfinzi, mainly a lung cancer treatment, was granted accelerated
approval for the bladder cancer indication in 2017, and the
withdrawal does not impact markets outside the United States, the
company said.
The treatment failed the main goal of a late-state trial last year
and the decision was based in consultation with U.S. authorities,
the company said.
"While the withdrawal in previously treated metastatic bladder
cancer is disappointing, we respect the principles FDA set out when
the accelerated approval pathway was founded," Dave Fredrickson,
executive vice president of the company's oncology business
division, said in a statement.
[to top of second column] |
Imfinzi belongs to the immunotherapy class of treatments that boost
the body's own defences to fight cancer by using antibodies that
block or bind to foreign substances in the body.
AstraZeneca also said other U.S. indications for the drug, which
brought in $2.04 billion in global revenue last year, were not
affected by the withdrawal, adding that it was notifying healthcare
providers of the update.
(Reporting by Pushkala Aripaka in Bengaluru; Editing by Sriraj
Kalluvila)
[© 2021 Thomson Reuters. All rights
reserved.] Copyright 2021 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content |
