Atezolizumab Approved as First-Line Treatment for Advanced Bladder Cancer in Some Patients

Web Exclusives - FDA Approvals

On April 17, 2017, atezo­lizumab (Tecentriq; Genentech), a PD-L1–blocking antibody, received a new indication by the FDA as first-line treatment for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy. This is the first immunotherapy and the first PD-L1 inhibitor to receive FDA approval as first-line treatment for advanced bladder cancer in this subgroup of patients.

“It is encouraging to see continued progress in the treatment of advanced bladder cancer, which until last year had not seen any major advancements in more than 30 years. We are excited that Tecentriq is now a treatment option for people with advanced bladder cancer who are unable to receive a cisplatin-based chemotherapy as an initial treatment,” said Andrea Maddox Smith, Chief Executive Officer, Bladder Cancer Advocacy Network, in a press release.

This approval of atezolizumab was based on previously published results of the phase 2 IMvigor 210 clinical trial. Atezolizumab was approved last year for patients with locally advanced or metastatic bladder cancer.

Serious side effects with atezo­lizumab include pneumonitis, hepatitis, colitis, hormonal issues, neuropathy, meningitis, encephalitis, and eye inflammation, as well as severe infections and severe infusion reactions.

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Last modified: August 10, 2017
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