BMS Launches India's First LAG-3-Based Dual Immunotherapy for Metastatic Melanoma
核心洞察
Bristol Myers Squibb (搜索) launches RELOPDUO (搜索), a fixed-dose combination of nivolumab and relatlimab, in India following CDSCO approval.
RELOPDUO (搜索) is India's first LAG-3 (搜索)-based dual immunotherapy, indicated for unresectable or metastatic melanoma (搜索) in patients aged 12 years and older.
The Phase 2/3 RELATIVITY-047 trial demonstrated median progression-free survival of 10.1 months versus 4.6 months with nivolumab monotherapy.
Bristol Myers Squibb (搜索) (BMS) has announced the launch of RELOPDUO (搜索) in India, marking the country's first LAG-3 (搜索)-based dual immunotherapy for the treatment of unresectable or metastatic melanoma (搜索). The fixed-dose combination of nivolumab and relatlimab received approval from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services (DGHS), authorizing its sale and distribution across the country.
The therapy is indicated for adults and pediatric patients aged 12 years and older with unresectable or metastatic melanoma (搜索). RELOPDUO (搜索) combines the PD-1 (搜索) inhibitor nivolumab with the LAG-3 (搜索)-blocking antibody relatlimab in a single fixed-dose regimen, simultaneously targeting two distinct immune checkpoints to help restore the body's immune response against cancer cells.
Clinical Evidence from RELATIVITY-047
The CDSCO approval is supported by findings from the Phase 2/3 RELATIVITY-047 trial, which evaluated the dual immunotherapy against nivolumab monotherapy. In the study, RELOPDUO (搜索) demonstrated a median progression-free survival of 10.1 months compared with 4.6 months for nivolumab alone, representing a clinically meaningful improvement. The combination also exhibited a manageable safety profile consistent with the known mechanisms of action of both agents.
Addressing Unmet Needs in India
In India, melanoma (搜索) is often diagnosed late and includes aggressive subtypes such as mucosal melanoma, underscoring the need for timely access to innovative therapies. The introduction of RELOPDUO (搜索) addresses a significant unmet need in the treatment of unresectable or metastatic melanoma, expanding the therapeutic arsenal available to oncologists in the region.
"Advancing innovative immunotherapy approaches remains central to Bristol Myers Squibb (搜索)'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 (搜索) brings a scientifically differentiated dual immunotherapy to eligible patients, offering new hope to those living with unresectable or metastatic melanoma (搜索). This launch also reflects our continued commitment to advancing immuno-oncology by bringing evidence-based, differentiated treatment options to India."
RELOPDUO (搜索) is an oncologist-prescribed treatment and represents what BMS describes as an important scientific advancement in immuno-oncology, bringing a novel dual checkpoint inhibition strategy to Indian patients facing this challenging malignancy.