Dr. Reddy's Wins DCGI Nod for Toripalimab in Advanced Oesophageal Cancer, a Second Indian Indication for the PD-1 Drug
India's drug regulator has approved Dr. Reddy's Zytorvi (toripalimab) with chemotherapy as a first-line treatment for advanced oesophageal squamous cell carcinoma, backed by Phase 3 data showing a 42% lower risk of progression or death and no requirement for PD-L1 testing.
Hyderabad-based Dr. Reddy's Laboratories has received approval from India's drug regulator to use its immunotherapy Zytorvi (toripalimab) in one of the most common and deadly cancers in the country's oesophageal-cancer burden. The company said on 21 October 2026 that the Central Drugs Standard Control Organisation (CDSCO), under the Drugs Controller General of India (DCGI), approved toripalimab in combination with cisplatin and paclitaxel as a first-line treatment for unresectable, advanced, recurrent or metastatic oesophageal squamous cell carcinoma (ESCC). The company cited a CDSCO letter dated 24 September 2026.
What the approval covers
This is toripalimab's second approved indication in India. Dr. Reddy's launched the drug in India under the Zytorvi brand in late 2024 for recurrent or metastatic nasopharyngeal carcinoma. The new label extends it to ESCC, the dominant subtype of oesophageal cancer in India and across Asia.
The approval rests on the international Phase 3 JUPITER-06 trial. Reported results:
- Toripalimab plus chemotherapy reduced the risk of disease progression or death by 42% compared with chemotherapy alone.
- Median overall survival was 17.7 months with the combination, versus 12.9 months with chemotherapy alone.
Reports also note that the Indian approval does not require patients to be selected by PD-L1 expression. Doctors therefore do not need a PD-L1 biomarker test before prescribing it in this setting. That matters in a health system where access to such testing varies widely.
How the drug works
Toripalimab is a monoclonal antibody against PD-1, a "checkpoint" receptor on immune T-cells. Tumours often use the PD-1 pathway to switch off the immune attack against them. Blocking PD-1 releases that brake so the immune system can recognise and attack cancer cells. Combining it with chemotherapy kills tumour cells directly and can also make the tumour more visible to the immune system.
The partnership behind it
Toripalimab was developed by China's Shanghai Junshi Biosciences. In May 2023, Dr. Reddy's signed a licensing deal with Junshi to develop and commercialise the drug in 21 countries. The core territory includes India, Brazil, Mexico, South Africa and several Latin American markets, with options for Australia, New Zealand and others. Junshi was eligible for up to US$728.3 million in upfront payments, fees and milestones, plus royalties on sales.
The deal reflects Dr. Reddy's strategy of building an oncology biologics portfolio in emerging markets. It in-licenses innovative molecules and uses its regulatory and commercial reach in countries where large multinational brands are often too expensive for most patients. Toripalimab has also been approved by regulators in other markets, including the United States, the European Union and the United Kingdom.
Why it matters
Oesophageal cancer is a major and under-discussed problem in India. It is among the leading causes of cancer deaths in the country, and ESCC, linked to tobacco, alcohol, diet and very hot beverages, accounts for most cases. Many patients are diagnosed late, when the disease can no longer be operated on and chemotherapy alone gives limited survival.
Checkpoint inhibitors have changed first-line treatment for advanced ESCC worldwide over the past few years, but cost has kept them out of reach for most Indian patients. A second, competitively positioned PD-1 option from a large Indian company, approved without a mandatory biomarker test, could widen access, particularly as Indian firms also bring cheaper biosimilars of nivolumab and pembrolizumab to market.
The approval adds to a busy period for immuno-oncology in India. It does not by itself settle questions of pricing, insurance coverage or inclusion in public schemes. Those decisions will determine how many of the patients who could benefit actually receive the drug.
Sources
- Business Standard: https://www.business-standard.com/companies/news/dr-reddys-zytorvi-dcgi-approval-oesophageal-cancer-toripalimab-126102100639_1.html
- Stock Titan (Dr. Reddy's Form 6-K): https://www.stocktitan.net/sec-filings/RDY/6-k-dr-reddys-laboratories-ltd-current-report-foreign-issuer-a0e1ffd53416.html
- Channel IAM: https://en.channeliam.com/2026/10/22/dr-reddys-zytorvi-toripalimab-oesophageal-cancer-approval/
- HDFC Sky: https://hdfcsky.com/news/dr-reddys-gets-dcgi-approval-for-zytorvi-in-esophageal-cancer-shares-rise-0-31percent
- Sahi: https://www.sahi.com/news/dr-reddy-s-gets-dcgi-approval-for-zytorvi-showing-42-risk-reduction
- BioSpectrum Asia (2023 licensing deal): https://www.biospectrumasia.com/news/97/22418/junshi-biosciences-dr-reddys-to-develop-and-commercialise-oncology-drug-in-21-countries.html
- Junshi Biosciences press release (2023): https://www.junshipharma.com/wp-content/uploads/2023/05/Junshi-Biosciences-Announces-Collaboration-with-Dr.-Reddys-to-Develop-and-Commercialize-Toripalimab-in-21-Countries.pdf
- BioSpectrum India (2024 India launch): https://biospectrumindia.com/news/73/25413/dr-reddys-launches-toripalimab-in-india-for-treatment-of-nasopharyngeal-carcinoma.html