|
 Basel-based Roche said in a statement it was withdrawing the U.S.
indication for Tecentriq, with some $3 billion in 2020 sales, in
prior-platinum treated metastatic urothelial carcinoma.
In February, AstraZeneca announced a similar move for its $2
billion-per-year drug Imfinzi.
Both Tecentriq and Imfinzi aim to take the brakes off the immune
system by binding with a protein called PD-L1, or programmed death-ligand
1, expressed on tumor cells and which is seen in helping prevent the
immune system from recognising it as cancer.
After so-called accelerated U.S. Food and Drug Administration (FDA)
approval for bladder cancer, however, the drugs failed to deliver
positive follow-up data required by regulators, prompting
discussions that led to the medicines being dropped in this
indication.
Other treatment areas for Tecentriq and Imfinzi are not impacted by
the companies' separate moves.
"This decision was made in consultation with the U.S. Food and Drug
Administration as part of an industry-wide review of accelerated
approvals with confirmatory trials that have not met their primary
endpoint(s) and have yet to gain regular approvals," Roche said.
[to top of second column] |
 Tecentriq initially won
accelerated FDA approval in 2016 for people
previously treated for the most common form of
bladder cancer, but was required to gather
follow-up data in order to win regular approval.
Doubts emerged quickly, however, as Roche said
in 2017 Tecentriq failed to show a survival
benefit in second-line bladder cancer, raising
questions over whether the FDA should reverse
the accelerated approval.
Tecentriq's other approved indications include
non-small cell lung cancer, small cell lung
cancer, certain types of bladder cancer, a kind
of triple negative breast cancer and for liver
cancer.
(Reporting by John Miller; editing by Lincoln
Feast and Jason Neely)
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