Trial Profile
A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer After Failure With Platinum-Containing Chemotherapy
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 13 Jan 2022
Price :
$35
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At a glance
- Drugs Atezolizumab (Primary) ; Docetaxel; Paclitaxel; Vinflunine
- Indications Bladder cancer; Carcinoma; Renal cancer; Ureteral neoplasms; Urethral cancer; Urogenital cancer
- Focus Registrational; Therapeutic Use
- Acronyms IMvigor 211
- Sponsors Chugai Pharmaceutical; Roche
- 08 Mar 2021 According to a Genentech media release, subsequently, the FDA designated IMvigor130 study as the PMR which will still continue until the final analysis. However, as the treatment landscape in prior-platinum (second-line) mUC has rapidly evolved with the emergence of new treatment options, the company is voluntarily withdrawing this indication in recognition of the principles of the Accelerated Approval Program.
- 08 Mar 2021 According to a Genentech media release, Tecentriq was granted accelerated approval in 2016 for the treatment of prior-platinum treated mUC based on the results from the IMvigor210 study (Cohort 2). Continued approval for this indication (mUC, bladder cancer) was contingent upon the results of IMvigor211, the original PMR for the prior-platinum mUC indication. This study did not meet its primary endpoint of overall survival in the PD-L1 high patient population.
- 08 Mar 2021 According to a Genentech media release, the company is voluntarily withdrawing the U.S. indication for Tecentriq (atezolizumab) in prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer). This decision was made in consultation with the U.S. FDA as part of an industry-wide review of accelerated approvals.The company will work with the FDA over the coming weeks to complete the withdrawal process.