NEW YORK – Genentech on Monday said it will voluntarily stop selling its immunotherapy Tecentriq (atezolizumab) as a first-line option for certain bladder cancer patients, including those with PD-L1 expression in at least 5 percent of tumor-infiltrating immune cells.
The US Food and Drug Administration granted accelerated approval to Tecentriq in 2017 as a treatment for locally advanced or metastatic urothelial cancer patients who can't receive cisplatin-based chemotherapy, based on the drug's impact on overall response rate and duration of response from the IMvigor210 study. In 2018, the drug's indication was narrowed so that Tecentriq was available for advanced bladder cancer patients who can't have cisplatin-containing chemo and whose tumors have high PD-L1 expression, or patients who aren't eligible for any platinum-containing chemotherapy regardless of their PD-L1 status.
Last year, as part of an industrywide review of FDA's accelerated approval program, the agency's Oncologic Drugs Advisory Committee voted 10 to 1 in favor of maintaining accelerated approval for Tecentriq's 2018 indication while the company awaited the final overall survival readout from the confirmatory post-market study IMvigor130.
Now, Genentech has decided to pull this indication after IMvigor130 failed to show that Tecentriq plus platinum-based chemo has an overall survival advantage over chemotherapy when given a first-line option for advanced bladder cancer patients. The firm plans to share the trial data at an upcoming medical meeting.
"While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA's Accelerated Approval Program," Levi Garraway, Genentech's chief medical officer and head of global product development, said in a statement. "There is 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."
Genentech plans to work with the FDA to complete the process of withdrawing Tecentriq in the coming weeks.
In May 2021, Genentech also pulled its FDA accelerated approval for Tecentriq in platinum chemo-treated bladder cancer patients after the IMvigor211 confirmatory trial showed the drug did not improve overall survival in the PD-L1-high patient population.