Instant Report

Date: 09-Mar-2021

Roche Joins The FDA Accelerated Approval Revamp Team, Nixing A Tecentriq Bladder Cancer Nod

After similar moves by fellow immuno-oncology players Bristol Myers Squibb, AstraZeneca and Merck & Co., Roche has pulled a Tecentriq bladder cancer indication amid a long-overdue FDA campaign targeting accelerated approvals that have failed in confirmatory studies.


Roche is pulling Tecentriq’s approval in patients with metastatic urothelial carcinoma previously treated with chemotherapy, the company said Monday. Like the three other companies that withdrew PD-1/L1 indications recently, the Swiss drugmaker said it had made the decision as part of the FDA’s industrywide review of accelerated approvals.



Before it, AstraZeneca said it would remove the same second-line bladder cancer approval from Imfinzi’s U.S. label after the drug failed a confirmatory trial in previously untreated patients. Second-line bladder cancer was actually Tecentriq’s entry ticket into the U.S. market, making the Roche drug the first in the PD-1/L1 class to reach this type of cancer. That original 2016 go-ahead was based on tumor shrinkage data from the phase 2 IMvigor210 study.



But data unveiled in 2017 from the phase 3 IMvigor211 trial showed Tecentriq wasn’t better than chemotherapy at extending the lives of previously chemo-treated patients who had at least 5% of PD-L1 expression in tumor-infiltrating immune cells.


RELATED: After Imfinzi's double flop, AstraZeneca walks away from FDA bladder cancer nod


That confirmatory trial failure threatened Tecentriq’s application in the indication. But the FDA allowed the drug to keep that nod—without converting it to a regular approval, though. Instead, the agency designated the phase 3 IMvigor130 study in previously untreated patients as the new confirmation study.



That trial produced top-line data in 2019, demonstrating the combination of Tecentriq and chemo reduced the risk of tumor progression or death by 18% over solo chemo, regardless of PD-L1 status. At that interim analysis, overall survival showed a trend for improvement with the combo, but it fell short of crossing the statistical significance bar.