Roche withdraws atezolizumab indication for urothelial carcinoma
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Roche voluntarily withdrew atezolizumab’s indication in the United States for the treatment of adults with locally advanced or metastatic urothelial carcinoma.
The indication applied to use of atezolizumab (Tecentriq, Genentech) — an anti-PD-L1 antibody — by patients who are ineligible for cisplatin-containing chemotherapy and whose tumors express PD-L1, or those ineligible for platinum-containing chemotherapy regardless of PD-L1 status.
The company made the decision in consultation with the FDA, which previously granted accelerated approval to atezolizumab for this indication.
The randomized phase 3 IMvigor trial — conducted as part of postmarketing requirements to convert the accelerated approval to regular approval — assessed the addition of atezolizumab to platinum-based chemotherapy as first-line therapy for treatment-naive advanced bladder cancer.
The trial failed to meet one of its co-primary endpoints of improved OS with atezolizumab-chemotherapy vs. chemotherapy alone.
Data from IMvigor130 will presented at a medical meeting.
“[Although] we are disappointed with this withdrawal, we understand the need to uphold the principles of the U.S. FDA’s accelerated approval program, which brings innovative medicines to patients sooner,” Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development, said in a press release. “There is a considerable unmet need for effective and tolerable treatments for people living with advanced bladder cancer, and so we regret that the IMvigor130 trial did not cross the statistical threshold for overall survival.”
Roche’s decision does not affect other approved indications for atezolizumab in the United States. The agent is approved for certain patients with non-small cell lung cancer, liver cancer or melanoma.
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