Swiss pharma company Roche has announced that it will withdraw the US indication for Tecentriq in prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer).
The US Food and Drug Administration (FDA) granted Tecentriq (atezolizumab) accelerated approval for this indication based on the results from the IMvigor210 study.
For continued approval in bladder cancer, Tecentriq had to yield positive results in this trial as part of the specific post-marketing requirements (PMR) set out by the FDA to confirm the clinical benefit of the immunotherapy.
However, the study did not meet its primary endpoint of overall survival in the PD-L1 high patient population.
Although the FDA designated another study – IMvigor130 – as the PMR for Tecentriq in the metastatic bladder cancer indication, Roche said it is voluntarily withdrawing the drug because the treatment landscape has now ‘rapidly evolved with the emergence of new treatment options’.
“The accelerated approval programme allows people with difficult-to-treat cancers to receive certain new therapies earlier,” said Levi Garraway, chief medical officer and head of global product development, Roche.
“While the withdrawal of Tecentriq for prior-platinum treated bladder cancer is disappointing, Tecentriq continues to demonstrate benefits across multiple cancer types and therefore remains a meaningful treatment option for many patients,” he added.
In February, AstraZeneca also announced the voluntary withdrawal of its immunotherapy Imfinzi in the advanced bladder cancer indication in the US.