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Dr. Garcia on FDA Approval of Pembrolizumab in Bladder Cancer

Jorge Garcia, MD
Published: Wednesday, Jun 21, 2017



Jorge Garcia, MD, Department of Hematology and Oncology, Cleveland Clinic, discusses the May 2017 FDA approval of pembrolizumab (Keytruda) in patients with urothelial carcinoma.

This is a significant FDA approval for the field, as it is the first registration trial to demonstrate an improvement in survival for this patient population. This contrasts from the phase II studies of atezolizumab (Tecentriq), avelumab (Bavencio), and durvalumab (Imfinzi), for which the FDA approvals were based on encouraging response rates. Moreover, this trial shows that pembrolizumab can be given to patients in the first-line setting.


Jorge Garcia, MD, Department of Hematology and Oncology, Cleveland Clinic, discusses the May 2017 FDA approval of pembrolizumab (Keytruda) in patients with urothelial carcinoma.

This is a significant FDA approval for the field, as it is the first registration trial to demonstrate an improvement in survival for this patient population. This contrasts from the phase II studies of atezolizumab (Tecentriq), avelumab (Bavencio), and durvalumab (Imfinzi), for which the FDA approvals were based on encouraging response rates. Moreover, this trial shows that pembrolizumab can be given to patients in the first-line setting.



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