Roche withdraws immunotherapy Drug for Bladder Cancer How sweet could this timing be! Maybe Roche could be interested in teaming up with us now?
By killing NMIBC tumor earlier with our TLD1433 in early-stage and late-stage, they would avoid more metastasic bladder cancer cases over time!
Atezolizumab No Longer Available in US for a Certain Type of Bladder Cancer November 29, 2022 Atezolizumab is no longer available to treat patients with advanced or metastatic bladder cancer following the manufacturer’s decision to withdraw its U.S. indication after consulting with the FDA. The U.S. indication for atezolizumab (Tecentriq) to treat patients with previously untreated locally advanced or metastatic urothelial carcinoma — a type of bladder cancer — has been voluntarily withdrawn by the agent’s manufacturer, Roche, after consulting with the FDA.1
According to Roche, this withdrawal does not affect other FDA-approved indications for atezolizumab in the U.S. The withdrawal was made in accordance with the FDA’s Accelerated Approval program after results from the phase 3 IMvigor130 trial (NCT02807636) failed to meet the postmarketing requirement necessary to convert the accelerated approval for atezolizumab into regular approval. In the trial,
atezolizumab plus chemotherapy did not reach the co-primary end point of improved overall survival (OS) compared with chemotherapy alone in the treatment of patients with previously untreated advanced bladder cancer. “
While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA’s Accelerated Approval program, which brings innovative medicines to patients sooner,”
Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Roche, said regarding the decision. “We remain confident in the benefit [atezolizumab] offers to people diagnosed with some of the most difficult-to-treat forms of cancer. 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 [OS].”
Previously, the FDA’s Oncologic Drugs Advisory Committee voted 10-to-1 in favor of upholding the accelerated approval of atezolizumab in the treatment of patients with metastatic urothelial carcinoma in April 2021. This accelerated approval was originally granted in 2017 based on findings from the phase 2 IMvigor210 trial (NCT02108652), which demonstrated that atezolizumab produced promising responses in patients regardless of PD-L1 expression status.
The FDA then updated this indication to include patients with high PD-L1 expression based on data from the IMvigor130 trial in 2018.