Dr. Reddy’s Labs Receives CDSCO Approval for Zytorvi in ESCC Treatment

Dr. Reddy’s Laboratories has secured approval from the Central Drugs Standard Control Organisation (CDSCO) for its specialty oncology drug, Zytorvi (toripalimab), for a new indication. The drug is now approved for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC), in combination with cisplatin and paclitaxel.

Reader Takeaway: Zytorvi’s new ESCC indication expands Dr. Reddy’s oncology footprint without requiring specific PD-L1 biomarker patient screening.

What just happened

The CDSCO has officially cleared Zytorvi for a second indication in the Indian market. This follows the drug's initial launch in November 2024, which focused on recurrent or metastatic nasopharyngeal carcinoma. The approval follows a strategic licensing and commercialization agreement signed in 2023 with Shanghai Junshi Biosciences for 21 countries, including India.

Why this matters

Esophageal cancer is the fourth leading cause of cancer-related mortality in India, with ESCC representing roughly 80% of those cases. By securing this indication, Dr. Reddy’s positions Zytorvi as a primary treatment option. Clinical data from the Phase 3 JUPITER-06 trial showed that the combination therapy reduced the risk of disease or death by 42% compared to standard chemotherapy, while also extending median overall survival to 17.7 months.

What changes now

Clinical adoption may be streamlined as the approved indication does not require patients to undergo PD-L1 biomarker selection, allowing for a broader application across patient subgroups. This development directly supports the company’s stated goal of scaling its specialty oncology segment in the Indian market.

What to track next

Investors should monitor the commercial rollout of Zytorvi for this new indication and evaluate how effectively the product contributes to the broader oncology segment’s revenue growth in future quarterly earnings calls.