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Association details:
Biomarker:No biomarker
Cancer:Urothelial Cancer
Drug:Keytruda (pembrolizumab) (PD1 inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Title:

Merck’s KEYTRUDA (pembrolizumab) Approved in Japan for Use in the Treatment of Patients with Urothelial Carcinoma That is Unresectable with Radical Surgery Who Have Progressed Following Cancer Chemotherapy

Published date:
01/02/2018
Excerpt:
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, has been approved by the Japanese Ministry of Health, Labor and Welfare (MHLW) for the treatment of patients with radically unresectable urothelial carcinoma who progressed after cancer chemotherapy.
Evidence Level:
Sensitive: A1 - Approval
Published date:
07/17/2015
Excerpt:
Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy.
Evidence Level:
Sensitive: A1 - Approval
New
Source:
Excerpt:
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated:...are not eligible for any platinum-containing chemotherapy, or...who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinumcontaining chemotherapy.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:

Pembrolizumab for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy

Published date:
04/28/2021
Excerpt:
CONTRADICTORY EVIDENCE: Pembrolizumab is not recommended, within its marketing authorisation, for treating locally advanced or metastatic urothelial carcinoma in adults who have had platinum-containing chemotherapy.
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
...the NCCN panel recommends pembrolizumab, atezolizumab, nivolumab, durvalumab, avelumab, or erdafitinib as preffered second-line systemic therapy options after platinum-based therapy.
Evidence Level:
Sensitive: B - Late Trials
Title:

Merck’s KEYTRUDA® (pembrolizumab) Met Primary Endpoint of Disease-Free Survival (DFS) in Certain Patients With Muscle-Invasive Urothelial Carcinoma (MIUC) After Surgery

Published date:
10/05/2023
Excerpt:
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 AMBASSADOR (A031501) trial (KEYNOTE-123) evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, met one of its dual primary endpoints of disease-free survival (DFS) for the adjuvant treatment of patients with localized muscle-invasive urothelial carcinoma (MIUC) and locally advanced urothelial carcinoma versus observation.
Trial ID: