Mumbai, India – Bristol Myers Squibb (BMS) announced the launch of RELOPDUO™ [fixed-dose combination (FDC) of nivolumab and relatlimab] in India following an approval from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services (DGHS), authorising its sale and distribution. With this milestone, BMS becomes the only company in India to have received permission to offer three distinct immune-oncology assets, including the country’s first FDC of two immune checkpoint inhibitors. RELOPDUO™ is also India’s first LAG-3-based dual immunotherapy, representing an important scientific advancement in immuno-oncology and expanding treatment options for adult and paediatric patients 12 years of age or older with unresectable or metastatic melanoma.
RELOPDUO™ combines the PD‑1 inhibitor nivolumab with the LAG‑3‑blocking antibody relatlimab in a fixed‑dose combination regimen, simultaneously targeting two distinct immune checkpoints to help restore the body’s immune response against cancer cells. In India, melanoma is often diagnosed late and includes aggressive subtypes such as mucosal melanoma, underscoring the need for timely access to innovative therapies and addressing a significant unmet need in the treatment of unresectable or metastatic melanoma.
“Advancing innovative immunotherapy approaches remains central to Bristol Myers Squibb’s mission of improving outcomes for patients with difficult-to-treat cancers,” said Dr. Ankita Jain, Country Medical Director, Bristol Myers Squibb India. “The introduction of RELOPDUO™ brings a scientifically differentiated dual immunotherapy to eligible patients, offering new hope to those living with unresectable or metastatic melanoma. This launch also reflects our continued commitment to advancing Immuno-Oncology by bringing evidence-based, differentiated treatment options to India.”
The launch is supported by findings from the Phase 2/3 RELATIVITY‑047 study, which showed RELOPDUO™ increased median progression‑free survival compared with nivolumab monotherapy (10.1 months vs. 4.6 months). RELOPDUO™ demonstrated a manageable safety profile consistent with the known mechanisms of action. RELOPDUO™ is an oncologist-prescribed treatment. Healthcare professionals should consult the approved package insert for the complete indication and refer directly to the product label for specific warnings.
Bristol Myers Squibb has been present in India for over 20 years and is presently providing treatments in oncology, hematology and cardiology. BMS aims to offer best-in-class global treatments to patients in India and is committed to bringing more medicines to more patients faster.
