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Association details:

Biomarker:
No biomarker
Direction:
Sensitive

Evidence:

Evidence Level:
Sensitive: A1 - Approval
Published date:
06/19/2015
Excerpt:
OPDIVO as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.
Evidence Level:
Sensitive: A1 - Approval
Source:
Excerpt:
OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of...patients with locally advanced or metastatic urothelial carcinoma who...have disease progression during or following platinum-containing chemotherapy...have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Evidence Level:
Sensitive: A2 - Guideline
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
New
Title:
U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Opdivo (nivolumab) as Adjuvant Treatment for Patients with Muscle-Invasive Urothelial Carcinoma
Published date:
04/30/2021
Excerpt:
Bristol Myers Squibb today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma, based on results from the CheckMate -274 trial. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act...
Evidence Level:
Sensitive: B - Late Trials
Title:
Adjuvant Treatment with Opdivo (nivolumab) Demonstrates Statistically Significant and Clinically Meaningful Improvement in Disease-Free Survival in Patients with Muscle-Invasive Urothelial Carcinoma in Phase 3 CheckMate -274 Trial
Published date:
02/08/2021
Excerpt:
Bristol Myers Squibb...announced results from the Phase 3 CheckMate -274 trial, which showed that Opdivo (nivolumab) significantly improved disease-free survival (DFS) as an adjuvant treatment across all randomized patients with surgically resected, high-risk muscle-invasive urothelial carcinoma....demonstrating a median disease-free survival of 21.0 months compared to 10.9 months with placebo, a risk reduction of 30% (Hazard Ratio [HR] 0.70, 98.31% Confidence Interval [CI]: 0.54 – 0.89, p<0.001).
Trial ID:
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