ZURICH (SWITZERLAND) – Roche on Monday partnered with AstraZeneca in withdrawing cancer immunotherapies from US use for bladder cancer, which has already been put through a treatment of platinum-based chemotherapy, after follow-up studies couldn’t meet goals.
Basel-based Roche said in a statement it was pulling down the US indication for Tecentriq, with some $3 billion in 2020 sales, in platinum treated metastatic urothelial carcinoma conducted in advance.
In February, AstraZeneca announced a similar move for its $2 billion-per-year drug Imfinzi.
Tecentriq as well as Imfinzi aim to withdraw the immune system by merging it with a protein called PD-L1, or programmed death-ligand 1, expressed on tumor cells. It is considered to be helping to prevent the immune system from identifying it as cancer.
Following the supposed accelerated US Food and Drug Administration (FDA) approval for bladder cancer, however, the drugs weren’t able to deliver positive follow-up data, which was deemed necessary by regulators, lead to discussions over dropping the medicines in this indication.
Other treatment areas for Tecentriq and Imfinzi would not have an impact from the companies’ separate moves.
“This decision was made in consultation with the US 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.
Other approved indications of Tecentriq 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.