Dr. Reddy’s Receives Indian Approval for Zytorvi Immunotherapy to Treat Advanced Oesophageal Cancer

Hyderabad-based pharmaceutical major Dr. Reddy’s Laboratories has received regulatory approval in India for Zytorvi (toripalimab), an advanced immunotherapy medicine intended for the treatment of oesophageal squamous cell carcinoma (ESCC). The approval, announced on 21 October 2026, expands treatment options for adults with advanced forms of oesophageal cancer and strengthens the availability of modern cancer immunotherapies in India.

The Central Drugs Standard Control Organisation (CDSCO), under the Drugs Controller General of India (DCGI), has approved Zytorvi in combination with the chemotherapy medicines cisplatin and paclitaxel. The combination can be used as a first-line treatment for adults with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma.

The approval is supported by results from the Phase III JUPITER-06 clinical trial, which demonstrated improvements in disease control and overall survival when toripalimab was combined with chemotherapy. According to Dr. Reddy’s, the combination reduced the risk of disease progression or death by 42% compared with chemotherapy alone. The study also recorded median overall survival of 17.7 months, compared with 12.9 months among patients receiving chemotherapy without toripalimab.

This development represents the second approved indication for Zytorvi in India, following its earlier approval for the treatment of nasopharyngeal carcinoma. It also marks another step in Dr. Reddy’s efforts to expand access to innovative oncology medicines.

Zytorvi Receives Approval for Advanced Oesophageal Cancer

The latest regulatory approval permits the use of Zytorvi with cisplatin and paclitaxel in eligible adult patients diagnosed with advanced oesophageal squamous cell carcinoma.

The treatment is intended for patients whose cancer cannot be removed surgically, has returned after earlier treatment or has spread to other parts of the body. These conditions often require systemic treatment because surgery or localised therapy alone may not adequately control the disease.

Until the development of modern immunotherapies, chemotherapy formed a major component of systemic treatment for advanced oesophageal cancer. Although chemotherapy remains important, its effectiveness can be limited by tumour resistance, treatment-related toxicity and disease progression.

The introduction of immune checkpoint inhibitors has expanded treatment approaches by allowing doctors to combine conventional cancer medicines with therapies that support the body’s immune response against malignant cells.

Zytorvi belongs to this category of medicines. Its approval provides oncologists in India with an additional first-line treatment option for appropriately selected patients with advanced oesophageal squamous cell carcinoma.

Importantly, the Indian approval does not require patients to be selected according to their PD-L1 expression levels. This allows eligible patients to be considered for the approved treatment irrespective of this particular biomarker, following clinical evaluation.

Understanding Oesophageal Squamous Cell Carcinoma

Oesophageal cancer develops in the oesophagus, the muscular tube responsible for carrying food and liquids from the throat to the stomach.

The disease occurs when abnormal cells within the oesophageal tissues multiply uncontrollably and form malignant tumours. As the cancer progresses, it can interfere with swallowing, affect nutritional intake and spread to surrounding tissues or distant organs.

Oesophageal squamous cell carcinoma develops from the thin, flat squamous cells lining the inner surface of the oesophagus. It differs from oesophageal adenocarcinoma, which develops from glandular cells and is more commonly associated with the lower portion of the oesophagus.

According to information released by Dr. Reddy’s, squamous cell carcinoma accounts for approximately 80% of oesophageal cancer cases in India. The disease therefore represents a substantial component of the country’s oesophageal cancer burden.

Recognised risk factors include tobacco consumption, alcohol use and certain dietary and environmental exposures. The likelihood of developing the disease can also be influenced by age, nutritional status and other health-related factors.

Symptoms may include progressive difficulty swallowing, discomfort while eating, unexplained weight loss, persistent chest discomfort and regurgitation. However, early-stage disease may produce few noticeable symptoms, contributing to delayed diagnosis in some patients.

When oesophageal cancer is detected at an advanced stage, treatment becomes more complex. Medicines capable of improving disease control and extending survival are therefore particularly important for patients with unresectable or metastatic disease.

How Toripalimab Immunotherapy Works

Zytorvi contains toripalimab, a monoclonal antibody designed to interfere with a biological mechanism that cancer cells can exploit to evade the immune system.

The human immune system contains specialised cells known as T lymphocytes, or T cells, which can recognise and attack abnormal cells. However, the immune system also uses regulatory mechanisms to prevent excessive activity and damage to healthy tissues.

One such mechanism involves a protein called programmed cell death protein 1, or PD-1, which is present on the surface of certain immune cells.

When PD-1 interacts with proteins known as PD-L1 or PD-L2, inhibitory signals can reduce T-cell activity. Some cancer cells exploit this pathway to weaken immune responses directed against them.

Toripalimab binds to PD-1 and prevents its interaction with PD-L1 and PD-L2. By blocking this inhibitory pathway, the medicine helps restore the ability of certain immune cells to recognise and respond to cancer cells.

This mechanism differs fundamentally from conventional chemotherapy. While many chemotherapy medicines act by interfering with cellular division or other processes required for cancer cell growth, toripalimab targets an immune regulatory pathway.

Combining these approaches allows treatment to act through different biological mechanisms. Chemotherapy damages susceptible cancer cells, while immunotherapy can support the immune system’s ability to respond to the tumour.

The effectiveness of this combination depends on the cancer type, disease characteristics and individual patient factors. The JUPITER-06 clinical trial provides evidence supporting its use in the population covered by the new Indian approval.

Phase III JUPITER-06 Trial Demonstrates Improved Disease Control

The regulatory approval is supported by the Phase III JUPITER-06 study, a randomised clinical trial evaluating toripalimab in combination with chemotherapy for advanced or metastatic oesophageal squamous cell carcinoma.

The trial compared toripalimab combined with paclitaxel and cisplatin against chemotherapy administered with a placebo. Its objective was to determine whether adding the immune checkpoint inhibitor could improve clinical outcomes for patients receiving first-line systemic treatment.

According to the results cited in Dr. Reddy’s regulatory announcement, the toripalimab combination reduced the risk of disease progression or death by 42% compared with chemotherapy alone.

This finding represents a relative reduction in the measured risk over the trial’s observation period. It does not mean that 42% of patients were cured or that every patient experienced the same benefit.

The study also demonstrated an improvement in overall survival, an important measure of treatment effectiveness in advanced cancer.

The results support the use of toripalimab with chemotherapy as an additional treatment option for eligible patients. They also illustrate the growing role of immune checkpoint inhibition in cancers that have historically been difficult to treat successfully at advanced stages.

Median Overall Survival Increases to 17.7 Months

One of the most important findings from the JUPITER-06 trial concerns overall survival.

At the final overall survival analysis, patients receiving toripalimab with chemotherapy achieved a median overall survival of 17.7 months. Those receiving chemotherapy alone had a median overall survival of 12.9 months.

This represents a difference of approximately 4.8 months between the two treatment groups.

Median overall survival refers to the time at which half of the patients in a study group have died and half remain alive. It is a standard measure used in oncology trials to compare outcomes between treatments.

The difference observed in JUPITER-06 provides evidence of a survival benefit associated with adding toripalimab to the chemotherapy combination.

However, median survival does not predict how long an individual patient will live. Outcomes vary according to disease stage, general health, tumour characteristics, treatment response and other clinical factors.

The results nevertheless represent a meaningful advance in the clinical evidence available for treating advanced oesophageal squamous cell carcinoma.

Approval Does Not Require PD-L1-Based Patient Selection

An important feature of the Indian approval is that the approved indication does not require patient selection based on PD-L1 expression.

PD-L1 is a protein that can be expressed by cancer cells and other cells within the tumour environment. Its expression is sometimes measured in tumour samples to help guide treatment decisions involving immune checkpoint inhibitors.

For certain cancers and medicines, the level of PD-L1 expression influences whether an immunotherapy is recommended or approved.

The JUPITER-06 findings demonstrated clinical benefits across patient subgroups with different PD-L1 expression levels.

Consequently, the approved Zytorvi combination in India can be considered for eligible patients without imposing a specific PD-L1 expression threshold as a condition of treatment.

This distinction is relevant because biomarker requirements can influence treatment eligibility and the diagnostic investigations needed before therapy begins.

Nevertheless, the absence of a PD-L1 selection requirement does not mean that the treatment is appropriate for every patient with oesophageal cancer. Oncologists must still consider the approved indication, overall health, potential adverse effects and individual clinical circumstances.

Zytorvi Expands Beyond Nasopharyngeal Cancer Treatment

Dr. Reddy’s introduced toripalimab in India in November 2024 for the treatment of recurrent or metastatic nasopharyngeal carcinoma, a cancer affecting the upper part of the throat behind the nose.

The launch marked an important addition to the company’s portfolio of innovative oncology medicines. It also expanded the availability of an immune checkpoint inhibitor that had already received regulatory recognition in several international markets.

The latest approval for oesophageal squamous cell carcinoma extends the medicine’s use to a second cancer indication in India.

Although both cancers can involve squamous cells, they differ in their anatomical locations, disease characteristics and treatment requirements. Regulatory approval for each indication therefore depends on clinical evidence supporting the medicine’s safety and effectiveness in the relevant patient population.

By obtaining approval for advanced oesophageal cancer, Dr. Reddy’s can expand the clinical applications of toripalimab within the country’s oncology treatment landscape.

International Partnership with Junshi Biosciences

Dr. Reddy’s entered into a licensing and commercialisation agreement with Shanghai Junshi Biosciences in 2023 to develop and commercialise toripalimab across 21 countries, including India.

The agreement forms part of Dr. Reddy’s strategy to expand its pharmaceutical portfolio through partnerships involving innovative medicines.

Junshi Biosciences developed toripalimab as a monoclonal antibody targeting the PD-1 immune checkpoint pathway. The medicine has subsequently received regulatory approvals in several major pharmaceutical markets.

According to Dr. Reddy’s October 2026 announcement, toripalimab has received approvals from regulatory authorities including the United States Food and Drug Administration, European Medicines Agency and United Kingdom Medicines and Healthcare products Regulatory Agency.

The European authorisation includes first-line treatment of oesophageal squamous cell carcinoma without requiring selection according to PD-L1 expression. India’s new approval follows a similar approach to biomarker eligibility.

The collaboration demonstrates how international licensing arrangements can support the introduction of advanced therapies into India’s pharmaceutical market.

Dr. Reddy’s contribution centres on developing and commercialising the licensed medicine within its designated territories, helping expand treatment availability through its established pharmaceutical operations.

Safety and Clinical Considerations of Immunotherapy

Although immune checkpoint inhibitors have improved treatment outcomes for several cancers, they can also produce adverse effects that require medical supervision.

By stimulating immune activity, medicines such as toripalimab can sometimes cause the immune system to attack healthy organs and tissues. These complications, known as immune-mediated adverse reactions, may affect the lungs, liver, intestines, endocrine glands, skin and other organs.

Patients receiving toripalimab with chemotherapy may also experience adverse effects associated with cisplatin and paclitaxel, including nausea, fatigue, reduced blood-cell counts and peripheral nerve problems.

The combination treatment therefore requires careful patient assessment, monitoring and management by qualified oncology specialists.

Clinical decisions must take account of the patient’s overall condition, disease characteristics, previous treatments and potential risks. The medicine is intended for the specific patient population covered by its approved indication and is not a universal treatment for oesophageal cancer.

The improved survival outcomes observed in clinical trials demonstrate the treatment’s potential benefits while reinforcing the importance of appropriate medical supervision.

Strengthening Access to Advanced Cancer Treatment in India

The approval of Zytorvi for advanced oesophageal squamous cell carcinoma represents another development in India’s expanding cancer treatment landscape.

Modern oncology increasingly involves therapies that target specific biological mechanisms rather than relying exclusively on traditional chemotherapy.

Immunotherapy has become an important part of this transition, particularly for cancers in which clinical studies have established meaningful improvements in treatment outcomes.

The availability of additional approved medicines provides oncologists with more options when designing treatment strategies for eligible patients.

For patients with advanced oesophageal squamous cell carcinoma, the addition of toripalimab to chemotherapy offers a treatment approach supported by evidence from a large Phase III clinical trial.

The absence of a mandatory PD-L1 expression threshold for the approved indication may also simplify treatment eligibility assessment for some patients, although other clinical considerations remain essential.

Actual patient access will depend on factors such as medicine availability, treatment costs, healthcare infrastructure and the ability of specialised oncology centres to administer and monitor immunotherapy.

Dr. Reddy’s continuing expansion into innovative oncology medicines is particularly relevant as India’s pharmaceutical industry develops a stronger presence in complex therapies and specialised healthcare products.

Dr. Reddy’s Advances Its Oncology Portfolio

Dr. Reddy’s Laboratories has established a substantial presence in the global pharmaceutical industry through generic medicines, active pharmaceutical ingredients and specialised pharmaceutical products.

The company has also pursued partnerships and licensing arrangements to introduce innovative treatments in selected therapeutic areas.

Cancer treatment is an important part of this strategy because the increasing complexity of modern oncology requires access to different therapeutic approaches.

The addition of a second approved indication for Zytorvi strengthens the company’s immuno-oncology portfolio and broadens the clinical applications of one of its licensed innovative medicines.

The development also reflects the importance of integrating international pharmaceutical research with domestic regulatory approval and commercialisation capabilities.

Through such arrangements, Indian pharmaceutical companies can support the availability of therapies developed through advanced clinical research while strengthening their participation in the international biopharmaceutical industry.

A New Treatment Option for Advanced Oesophageal Cancer

The approval of Zytorvi in combination with cisplatin and paclitaxel represents a significant addition to the treatment options available for adults with advanced oesophageal squamous cell carcinoma in India.

The Phase III JUPITER-06 trial demonstrated a 42% relative reduction in the risk of disease progression or death and an improvement in median overall survival from 12.9 months to 17.7 months with the addition of toripalimab.

These findings provide clinical evidence supporting the combination’s use in the approved patient population.

For Dr. Reddy’s Laboratories, the approval expands the applications of an innovative immunotherapy already introduced in India for nasopharyngeal carcinoma.

More broadly, the development reflects the continuing progress of cancer treatment towards therapies that combine conventional medicines with advances in immunology and molecular medicine.

As India’s pharmaceutical industry strengthens its participation in innovative drug development, international licensing and specialised therapies, advances such as Zytorvi are contributing to a broader range of evidence-based treatment options for patients with serious cancers.

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References

1. Dr. Reddy’s Laboratories – Regulatory Approval Announcement, 21 October 2026

Company announcement concerning CDSCO/DCGI approval of Zytorvi (toripalimab) in combination with cisplatin and paclitaxel for first-line treatment of advanced oesophageal squamous cell carcinoma.

The announcement includes details of the approved indication, JUPITER-06 clinical trial results, PD-L1 eligibility and the company’s licensing agreement with Junshi Biosciences.

Official company website:

https://www.drreddys.com

The 21 October announcement was corroborated through publications reproducing the company’s release. A direct copy hosted on Dr. Reddy’s website was not independently located.

2. Dr. Reddy’s Laboratories – Official Press Release, 28 November 2024

Dr. Reddy’s Launches Toripalimab in India, the First and Only Immuno-Oncology Drug Approved for the Treatment of Nasopharyngeal Carcinoma.

Official documentation concerning the introduction of toripalimab in India, its mechanism of action and international regulatory status.

https://www.drreddys.com/cms/cms/sites/default/files/2024-11/Dr.%20Reddy%27s%20press%20release%20-%20launch%20of%20Toripalimab%20in%20India.pdf

3. Dr. Reddy’s Laboratories – Q1 FY2026–27 Investor Presentation, 22 July 2026

Official investor presentation documenting progress in the company’s oncology portfolio and commercial development of toripalimab.

https://www.sec.gov/Archives/edgar/data/1135951/000157587226000518/rdy0924_ex99-1.pdf

4. ClinicalTrials.gov – JUPITER-06 Clinical Trial

Official clinical trial registry maintained by the United States National Library of Medicine.

Clinical trial assessing toripalimab combined with chemotherapy in advanced or metastatic oesophageal squamous cell carcinoma.

https://clinicaltrials.gov/study/NCT03829969

5. Central Drugs Standard Control Organisation (CDSCO)

Government of India regulatory authority responsible for drug approvals and related pharmaceutical regulations.

https://cdsco.gov.in

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