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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Melanoma |
| Drug: | Opdualag (nivolumab/relatlimab-rmbw) (PD1 inhibitor, LAG-3 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
03/18/2022
Excerpt:
OPDUALAG is a combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
Title:
U.S. Food and Drug Administration Approves First LAG-3-Blocking Antibody Combination, Opdualag™ (nivolumab and relatlimab-rmbw), as Treatment for Patients with Unresectable or Metastatic Melanoma
Published date:
03/18/2022
Excerpt:
Bristol Myers Squibb (NYSE: BMY) today announced that OpdualagTM (nivolumab and relatlimab-rmbw), a new, first-in-class, fixed-dose combination of nivolumab and relatlimab, administered as a single intravenous infusion, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. The approval is based on the Phase 2/3 RELATIVITY-047 trial, which compared Opdualag (n=355) to nivolumab alone (n=359).
Source:
Title:
Health-related quality of life with nivolumab plus relatlimab versus nivolumab monotherapy in patients with previously untreated unresectable or metastatic melanoma: RELATIVITY-047 trial
Published date:
03/22/2023
Excerpt:
Results from the RELATIVITY-047 trial show that the PFS benefit with NIVO + RELA FDC over NIVO was obtained with stable patient-reported HRQoL, supporting NIVO + RELA as a first-line treatment option for patients with advanced melanoma.
DOI:
10.1016/j.ejca.2023.03.014
Trial ID:
Title:
U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for LAG-3-Blocking Antibody Relatlimab and Nivolumab Fixed-Dose Combination as Treatment for Patients with Unresectable or Metastatic Melanoma
Published date:
09/20/2021
Excerpt:
Bristol Myers Squibb...today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for the LAG-3-blocking antibody relatlimab and nivolumab fixed-dose combination, administered as a single infusion, for the treatment of adult and pediatric patients (12 years and older and weighing at least 40 kg) with unresectable or metastatic melanoma.
Trial ID:
