Dr Reddy's gets DCGI approval for Zytorvi in esophageal cancer
- Dr. Reddy's Laboratories received DCGI approval for Zytorvi in advanced esophageal squamous cell carcinoma (ESCC)
- This marks the second approved indication for Zytorvi in India, expanding beyond nasopharyngeal carcinoma
- Phase 3 trials demonstrated a 42% reduction in risk of disease progression or death compared to chemotherapy alone
- Esophageal cancer accounts for approximately 8.1% of all cancer deaths in India, with ESCC comprising 80% of cases
*this image is generated using AI for illustrative purposes only.
Dr. Reddy's Laboratories received approval from the Drugs Controller General of India (DCGI) for Zytorvi® (toripalimab) in combination with cisplatin and paclitaxel for first-line treatment of advanced esophageal squamous cell carcinoma (ESCC). This marks the drug's second approved indication in India.
The approval expands the use of Zytorvi® beyond nasopharyngeal carcinoma. It supports first-line treatment for adult patients with unresectable advanced, recurrent or metastatic ESCC. The decision follows a Phase 3 trial showing a 42% reduction in disease progression or death risk compared to chemotherapy alone.
Clinical efficacy and trial data
The regulatory clearance is supported by results from the JUPITER-06 Phase 3 trial. Data from the study indicates significant survival benefits for patients receiving the combination therapy.
| Metric | Toripalimab + Chemo | Chemo Alone |
|---|---|---|
| Median Overall Survival | 17.7 months | 12.9 months |
| Risk Reduction | 42% | N/A |
Clinical benefit was observed across PD-L1-expression subgroups. The approved indication in India does not require patient selection based on PD-L1 expression, allowing broader eligibility for appropriate patients.
Market context and licensing
Esophageal cancer was the fourth leading cause of cancer-related death in India in 2024, accounting for approximately 8.1% of all cancer deaths. ESCC is the predominant subtype, representing about 80% of all esophageal cancer cases in the country.
Dr. Reddy's entered into a licensing and commercialization agreement with Junshi Biosciences in 2023 for toripalimab across 21 countries. The company launched Zytorvi® in India in November 2024 for recurrent or metastatic nasopharyngeal carcinoma, making India the third country globally to access the medicine after China and the United States.
Globally, toripalimab is approved by regulatory authorities including the U.S. Food and Drug Administration (USFDA), the European Medicines Agency (EMA), and the UK Medicines and Healthcare products Regulatory Agency (MHRA). The EMA approval specifically covers first-line treatment of ESCC irrespective of PD-L1 expression.
What the numbers show
The divergence between the 42% risk reduction and the 4.8-month absolute gain in median overall survival highlights the clinical impact of adding immunotherapy to standard chemotherapy. With ESCC comprising 80% of local cases, this approval addresses a significant portion of the disease burden in a market where esophageal cancer ranks as the fourth leading cause of cancer mortality.
Historical Stock Returns for Dr Reddys Laboratories
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| +0.14% | +1.21% | +5.00% | +0.70% | -0.92% | +29.57% |
How will the lack of PD-L1 expression requirements in India's approval impact Zytorvi's market penetration compared to competitors requiring biomarker testing?
What specific pricing strategies or reimbursement pathways is Dr. Reddy's pursuing to ensure accessibility for the large ESCC patient population in India?
How might this approval influence Dr. Reddy's revenue projections for FY2025 given the high prevalence of ESCC in the region?
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