Bristol Myers Squibb has received CDSCO approval for RELOPDUO, a fixed‑dose combo of nivolumab and relatlimab, marking India's first LAG‑3‑based dual immunotherapy for patients aged 12 and above with unresectable or metastatic melanoma.

Key Takeaways

  • RELOPDUO is India’s first LAG‑3‑based dual immunotherapy.
  • Combining nivolumab (PD‑1) and relatlimab (LAG‑3) improves progression‑free survival.
  • Approved for adults and children 12 years and older with unresectable or metastatic melanoma.

Bristol Myers Squibb (BMS) announced the launch of RELOPDUO, a fixed‑dose combination of nivolumab and relatlimab, after securing approval from the Central Drugs Standard Control Organisation (CDSCO).

RELOPDUO is the first LAG‑3‑targeted dual immunotherapy in India, indicated for adults and children aged 12 years or older with unresectable or metastatic melanoma. Nivolumab blocks the PD‑1 checkpoint, while relatlimab inhibits LAG‑3, together enhancing the immune system’s ability to attack cancer cells.

Historical Background

Immunotherapy began gaining traction in the 1990s with the first PD‑1 inhibitors entering trials. Over the past two decades, multiple monoclonal antibodies have been developed, yet targeting LAG‑3 in combination is a recent breakthrough. The Phase 2/3 RELATIVITY‑047 trial demonstrated superior progression‑free survival compared with nivolumab alone, paving the way for rapid Indian approval.

Why This Matters

BozokMedia analysis shows that the introduction of a dual checkpoint inhibitor in India could dramatically improve survival rates for melanoma patients, a disease that previously had limited therapeutic options in the region.

"Dual checkpoint inhibition not only extends patient survival but also expands the therapeutic arsenal against aggressive melanoma," says Dr. Anshu Sharma, oncology specialist.
Did You Know?: Melanoma accounts for a disproportionate share of skin‑cancer deaths worldwide, with five‑year survival dropping from 80% to 20% when diagnosed at an advanced stage.

Frequently Asked Questions

Q1: What are the side effects of RELOPDUO?
A: Common side effects include fatigue, skin rash, and gastrointestinal upset; severe cases may involve immune‑mediated adverse events.

Q2: Can this therapy be used for cancers other than melanoma?
A: Currently, RELOPDUO is approved solely for melanoma, though clinical trials are exploring its efficacy in other tumor types.