Bristol Myers Squibb (BMS) has launched RELOPDUO in India, making it the country's first LAG-3-based dual immunotherapy and the first fixed-dose combination (FDC) of two immune checkpoint inhibitors for the treatment of unresectable or metastatic melanoma.

The approval from the Central Drugs Standard Control Organisation (CDSCO) authorises the sale and distribution of RELOPDUO, a fixed-dose combination of nivolumab and relatlimab, for adult and paediatric patients aged 12 years and above with unresectable or metastatic melanoma. 

With this launch, BMS becomes the only company in India to offer three distinct immune-oncology therapies.

RELOPDUO combines the PD-1 inhibitor nivolumab with the LAG-3-blocking antibody relatlimab in a single regimen, targeting two complementary immune checkpoints to help restore the body's immune response against cancer cells. 

The therapy addresses a significant unmet need in India, where melanoma is often diagnosed at advanced stages and includes aggressive subtypes such as mucosal melanoma.

Dr. Ankita Jain, Country Medical Director, Bristol Myers Squibb India, said, "Advancing innovative immunotherapy approaches remains central to Bristol Myers Squibb's mission of improving outcomes for patients with difficult-to-treat cancers.  

“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,” added Jain. 

The launch is supported by results from the Phase 2/3 RELATIVITY-047 clinical trial, which demonstrated that RELOPDUO nearly doubled median progression-free survival compared with nivolumab monotherapy, achieving 10.1 months versus 4.6 months.  

The therapy also demonstrated a manageable safety profile consistent with the known mechanisms of action of its two components.

RELOPDUO is a prescription medicine intended for use under the supervision of qualified oncologists. Healthcare professionals are advised to refer to the approved prescribing information for complete indications, safety warnings, and administration guidelines.