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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Esophageal Cancer |
| Drug: | Opdivo (nivolumab) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
ONO Receives Approval of Opdivo® (nivolumab) for Expanded Use for Two Indications in Japan
Published date:
11/25/2021
Excerpt:
Ono Pharmaceutical Co., Ltd...and Bristol-Myers Squib...today announced that ONO has received the approvals of Opdivo® (generic name: nivolumab) Intravenous Infusion (“Opdivo”), a human anti-PD-1 monoclonal antibody in Japan, for expanded use for the first-line treatment of unresectable advanced or recurrent gastric cancer in combination with chemotherapy, and adjuvant treatment of esophageal cancer...
Secondary therapy:
Chemotherapy
Title:
Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) as Adjuvant Treatment for Esophageal or Gastroesophageal Junction Cancer Patients with Residual Pathologic Disease Following Chemoradiotherapy
Published date:
07/30/2021
Excerpt:
Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (CRT).
Title:
Bristol Myers Squibb Receives Positive CHMP Opinion for Opdivo (nivolumab) as Adjuvant Treatment for Esophageal or Gastroesophageal Junction Cancer Patients with Residual Pathologic Disease Following Chemoradiotherapy
Published date:
06/25/2021
Excerpt:
Bristol Myers Squibb: today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (CRT).
Source:
Excerpt:
Esophageal and Esophagogastric Junction Cancers: Preferred Regimens...Nivolumab…
Source:
Title:
Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer
Published date:
04/01/2021
Excerpt:
The median follow-up was 24.4 months. Among the 532 patients who received nivolumab, the median disease-free survival was 22.4 months (95% confidence interval [CI], 16.6 to 34.0), as compared with 11.0 months (95% CI, 8.3 to 14.3) among the 262 patients who received placebo (hazard ratio for disease recurrence or death, 0.69; 96.4% CI, 0.56 to 0.86; P<0.001).
DOI:
10.1056/NEJMoa2032125
Trial ID:
Title:
U.S. Food and Drug Administration Accepts for Priority Review Application for Opdivo® (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer
Published date:
01/20/2021
Excerpt:
...Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) for the treatment of patients with resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting, after neoadjuvant chemoradiation therapy (CRT). The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 20, 2021.
Title:
CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival
Published date:
08/11/2020
Excerpt:
...Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis. In the trial, treatment with Opdivo following neoadjuvant chemoradiation therapy (CRT) and complete surgical resection demonstrated a statistically significant improvement in the primary endpoint of DFS compared to placebo in the all-randomized population.
Trial ID:
