Shots:
- The company reported the voluntary withdrawal of the Tecentriq (atezolizumab) indication in the US for prior-platinum treated mUC, bladder cancer
- The withdrawal was made in consultation with the US FDA to review the accelerated approvals with confirmatory trials that have not met 1EPs and have yet to gain regular approvals. The decision does not affect other approved indications for Tecentriq
- In 2016, Tecentriq has received accelerated approval based on the results from IMvigor210 study (Cohort 2) while the continued approval was contingent on the results of IMvigor211 study, which did not meet its 1EPs. Additionally, FDA designated the IMvigor130 study as the PMR which will continue until the final analysis
Click here to read full press release/ article | Ref: Roche | Image: Bloomberg
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