Roche withdraws PD-L1 inhibitor Tecentriq for bladder cancer indications in the U.S.

Finishingrainbow

Two weeks after AstraZeneca withdrew Imfinzi (duvaluzumab) as an indication for previously treated adults with locally advanced or metastatic bladder cancer in the United States, on March 8, Roche also announced that it would voluntarily withdraw Tecentriq in the United States.

According to the open-label, multi-center, single-arm phase II clinical study of IMvigor210, the safety and effectiveness of Tecentriq are evaluated in patients with advanced urothelial carcinoma.

The FDA's "Accelerated Approval Program" allows people with refractory cancers to receive certain new therapies as soon as possible.

In the 2017 phase III clinical trial-IMvigor211, Roche compared Tecentriq with chemotherapy head-to-head, trying to use it as a first-line treatment for specific advanced bladder cancer.

Regarding the failure of IMvigor211, the FDA did not withdraw Tecentriq's bladder cancer indications, but continued to retain Tecentriq's second-line/first-line indications until the IMvigor130 study continued to obtain the final results before making a decision.

In the IMvigor130 study, Tecentriq continues to conduct head-to-head trials with chemotherapy.

Although this research is still in progress, because the clinical needs for the second-line treatment of bladder cancer have been met in recent years with the approval of some new first-in-class therapies, Roche has decided to withdraw Tecentriq from the second-line treatment market for this indication.