Dr. Reddy’s Zytorvi approved for advanced esophageal cancer

In the Phase 3 JUPITER-06 trial, toripalimab plus chemotherapy reduced the risk of disease or death by 42% versus chemotherapy alone.

Rhea-AI Filing Summary

Dr. Reddy’s Laboratories (RDY) received approval from India’s Central Drugs Standard Control Organisation under the Drugs Controller General of India for Zytorvi (toripalimab) with cisplatin and paclitaxel as first-line treatment for adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This is Zytorvi’s second approved indication in India, following nasopharyngeal carcinoma, and the ESCC indication does not require patient selection based on PD-L1 expression.

The Phase 3 JUPITER-06 trial supporting the approval reported a 42% reduction in the risk of disease or death versus chemotherapy alone. At final overall-survival analysis, median overall survival was 17.7 months with toripalimab plus chemotherapy and 12.9 months with chemotherapy alone; clinical benefit was observed across PD-L1-expression subgroups. Under a 2023 licensing and commercialization agreement with Shanghai Junshi Biosciences Co., Ltd., Dr. Reddy’s holds exclusive rights to develop and commercialize toripalimab in 21 countries.

In India, esophageal cancer was the fourth leading cause of cancer-related death in 2024, accounting for approximately 8.1% of cancer deaths. ESCC accounts for approximately 80% of esophageal cancer cases in India.

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• Moderate pointZytorvi’s second Indian indication covers first-line treatment of advanced ESCC.

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Key Figures

Reduction in risk of disease or death: 42% Median overall survival with toripalimab combination: 17.7 months Median overall survival with chemotherapy alone: 12.9 months +3 more

6 metrics

Reduction in risk of disease or death 42% Toripalimab with paclitaxel and cisplatin versus chemotherapy alone in the Phase 3 JUPITER-06 trial

Median overall survival with toripalimab combination 17.7 months Final overall-survival analysis

Median overall survival with chemotherapy alone 12.9 months Final overall-survival analysis

Countries with exclusive toripalimab development and commercialization rights 21 countries Rights held by Dr. Reddy’s under its agreement with Shanghai Junshi Biosciences

Share of cancer deaths in India attributed to esophageal cancer Approximately 8.1% 2024

Share of esophageal cancer cases in India that are ESCC Approximately 80% India

Key Terms

esophageal squamous cell carcinoma (ESCC), PD-L1 expression, programmed death receptor-1, monoclonal antibody, +1 more

5 terms

esophageal squamous cell carcinoma (ESCC) medical

"treatment for adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma"

PD-L1 expression medical

"does not require patient selection based on PD-L1 expression"

PD-L1 expression is the amount of a specific protein shown on tumor or immune cells that acts like a “do not attack” sign to the immune system. Tests that measure PD-L1 help predict whether immune-boosting cancer drugs will work for a patient; higher or lower levels can affect clinical trial success, regulatory approval, pricing and how many patients are eligible, so investors use it to gauge a drug’s market potential and risk.

programmed death receptor-1 medical

"directed against programmed death receptor-1, or PD-1"

A protein found on certain immune cells that acts like a brake, helping prevent the immune system from attacking healthy tissue; some cancers exploit this brake to hide from immune attacks. Drugs that block programmed death receptor‑1 (PD‑1) release that brake, allowing the immune system to attack tumors — a mechanism that can create high-value medicines but also brings clinical trial, safety and regulatory risks that matter to investors.

monoclonal antibody medical

"humanised IgG4 monoclonal antibody"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

median overall survival medical

"median overall survival was 17.7 months"

Median overall survival is the middle point of how long patients live after starting treatment, meaning half live longer and half live shorter. It helps doctors understand how effective a treatment is and gives patients an idea of what to expect about their future.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did India approve for RDY’s Zytorvi?

India approved Zytorvi (toripalimab) with cisplatin and paclitaxel as first-line treatment for adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma. This is the medicine’s second approved indication in India.

What results supported RDY’s Zytorvi approval?

In the Phase 3 JUPITER-06 trial, toripalimab with chemotherapy reduced the risk of disease or death by 42% compared with chemotherapy alone. At final overall-survival analysis, median overall survival was 17.7 months with the combination and 12.9 months with chemotherapy alone.

Does RDY’s Indian Zytorvi indication require PD-L1 selection?

No. The approved Indian indication does not require patient selection based on PD-L1 expression.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR 10/21/2026 - 06:21 AM EDT Accepted by SEC EDGAR 10/21/2026 - 06:21 AM EDT Learn about SEC filing dates

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13A-16 OR 15D-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

October, 2026

Commission File Number 1-15182

DR. REDDY’S LABORATORIES LIMITED

(Translation of registrant’s name into English)

8-2-337, Road No. 3, Banjara Hills

Hyderabad, Telangana 500 034, India

+91-40-49002900

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F  x                               Form 40-F   ¨

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ______

Note:  Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  ______

Note:  Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes  ¨                                     No   x

If “Yes” is marked, indicate below the file number assigned to registrant in connection with Rule 12g3-2(b): 82-________.

EXHIBITS

Exhibit Number		Description of Exhibits
99.1		Intimation dated October 21, 2026

2

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	DR. REDDY’S LABORATORIES LIMITED (Registrant)
Date: October 21, 2026	By:	/s/ K Randhir Singh
		Name:	K Randhir Singh
		Title:	Company Secretary

3

Exhibit 99.1 

Dr. Reddy's Laboratories Ltd. 8-2-337, Road No. 3, Banjara Hills Hyderabad – 500 034, Telangana, India CIN: L85195TG1984PLC004507 Tel:       + 91 40 4900 2900 Fax:     + 91 40 4900 2999 Email: mail@drreddys.com Web:   www.drreddys.com

October 21, 2026

National Stock Exchange of India Ltd. (Scrip Code: DRREDDY)

BSE Limited (Scrip Code: 500124)

New York Stock Exchange Inc. (Stock Code: RDY)

NSE IFSC Ltd. (Stock Code: DRREDDY)

Dear Sir/Madam,

Ref: Disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015

Please find enclosed a Press Release viz. “Dr. Reddy’s Receives DCGI Approval for Zytorvi® (toripalimab) in Advanced Esophageal Squamous Cell Carcinoma, Its Second Approved Indication in India”

This is for your information and records.

Thanking you,

Yours faithfully,

For Dr. Reddy’s Laboratories Limited

K Randhir Singh

Company Secretary, Compliance Officer & Head-CSR

DR. REDDY'S LABORATORIES LTD. 8-2-337, Road No. 3, Banjara Hills, Hyderabad - 500034. Telangana, India.	CONTACT
CIN: L85195TG1984PLC004507 Tel: + 91 40 4900 2900	INVESTOR RELATIONS	MEDIA RELATIONS
Fax: + 91 40 4900 2999 Email: mail@drreddys.com Web: www.drreddys.com	AISHWARYA SITHARAM AISHWARYASITHARAM@DRREDDYS.COM	SANTOSH VYAS SANTOSHVYAS@DRREDDYS.COM

Dr. Reddy’s Receives DCGI Approval for Zytorvi® (toripalimab) in
Advanced Esophageal Squamous Cell Carcinoma, Its Second Approved
Indication in India

The approval expands the use of Zytorvi® beyond its initially approved indication in nasopharyngeal carcinoma (NPC)

Hyderabad, India; October 21, 2026: Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s,”) today announced that the Central Drugs Standard Control Organisation (CDSCO), under the Drugs Controller General of India (DCGI), has approved Zytorvi® (toripalimab) in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).¹

Dr. Reddy’s entered into a licensing and commercialization agreement with Junshi Biosciences in 2023 for toripalimab across 21 countries. 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).² Notably, the EMA approval is for first-line treatment of ESCC irrespective of PD-L1 expression.³ The approved indication in India similarly does not require patient selection based on PD-L1 expression, enabling appropriate patients to be considered for treatment regardless of their biomarker status.^1,3

In 2024, esophageal cancer was the fourth leading cause of cancer-related death in India, accounting for approximately 8.1% of all cancer deaths⁴. ESCC, the predominant subtype, accounts for approximately 80% of all esophageal cancer cases in India. Through Zytorvi®, Dr. Reddy’s Laboratories Ltd. aims to expand access to first-line immunotherapy for appropriate patients with advanced ESCC in India.

The approval is supported by the results from the Phase 3 JUPITER-06 trial. In the study, toripalimab in combination with paclitaxel and cisplatin reduced the risk of disease or death by 42% compared with chemotherapy alone.⁷ At the final overall-survival analysis, median overall survival was 17.7 months with toripalimab plus chemotherapy compared with 12.9 months with chemotherapy alone. Clinical benefit was observed across PD-L1-expression subgroups.⁸

M.V. Ramana, Chief Executive Officer, Global Generics, Dr. Reddy’s Laboratories, said:

“Following the approval of Zytorvi® in nasopharyngeal carcinoma, this second indication marks an important step in extending the reach of immunotherapy to patients with advanced esophageal squamous cell carcinoma. It gives physicians an additional first-line treatment option for appropriate patients. As we continue to build our oncology portfolio, our focus remains on bringing meaningful advances and expanding access to innovative treatment options."

About esophageal squamous cell carcinoma

Esophageal cancer begins in the tissues of the esophagus, the muscular tube that carries food and liquids from the throat to the stomach. ESCC develops from the squamous cells lining the esophagus.

Risk factors associated with ESCC include smoked and smokeless tobacco, alcohol consumption, areca-nut use, consumption of very hot beverages, poor diet and certain environmental and socioeconomic factors. Risk varies between individuals, and the presence of one or more risk factors does not mean that a person will necessarily develop cancer.

Progressive difficulty in swallowing, pain or discomfort when swallowing, unexplained weight loss, persistent chest discomfort and regurgitation may be associated with esophageal cancer. These symptoms may also be caused by other conditions and require evaluation by a qualified healthcare professional.^5,6

About Zytorvi® (toripalimab)

Zytorvi® contains toripalimab, a next-generation humanised IgG4 monoclonal antibody⁹ directed against programmed death receptor-1, or PD-1. By binding to PD-1, toripalimab blocks its interaction with PD-L1 and PD-L2, supporting T-cell activity against cancer cells.³

In 2023, Dr. Reddy’s entered into a licence and commercialisation agreement with Shanghai Junshi Biosciences Co., Ltd. for toripalimab. Under this agreement, Dr. Reddy’s holds exclusive rights to develop and commercialise toripalimab in 21 countries, including India, South Africa, Brazil and several countries in Latin America, Australia, New Zealand and nine other countries.² Dr. Reddy’s launched Zytorvi® in India in November 2024 for recurrent or metastatic nasopharyngeal carcinoma, making India the third country in the world, after China and the United States, to receive access to the medicine.²

Toripalimab is approved by regulatory authorities including the U.S. Food and Drug Administration (USFDA), the EMA and the UK Medicines and Healthcare products Regulatory Agency (MHRA).² The European Commission authorised toripalimab for first-line ESCC in September 2024.³

About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include - USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance.

For more information, log on to: www.drreddys.com

Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward­looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults, currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2026. The company assumes no obligation to update any information contained herein.

References

1. CDSCO approval letter, Letter No. BIO/IMP/25/000057, dated 24th September 2026, approving Toripalimab for the treatment of Advanced Esophageal Squamous Cell Carcinoma. Data on file, Dr Reddy’s Laboratories Ltd.

2. Dr. Reddy’s Laboratories Ltd. Dr. Reddy’s launches toripalimab in India, the first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma [press release on the Internet]. Hyderabad: Dr. Reddy’s Laboratories Ltd; 2024 Nov 28 [cited 2026 Oct 5]. Available from: https://www.drreddys.com/cms/cms/sites/default/files/2024- 11/Dr.%20Reddy%27s%20press%20release%20-%20launch%20of%20Toripalimab%20in%20India.pdf

3. European Medicines Agency. Loqtorzi: European public assessment report [Internet]. Amsterdam: European Medicines Agency; 2024 [cited 2026 Oct 5]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/loqtorzi

4. International Agency for Research on Cancer. Global Cancer Observatory: GLOBOCAN 2024 India fact sheet [Internet]. Lyon: International Agency for Research on Cancer; 2026 [cited 2026 Oct 5]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/populations/356-india-fact-sheet.pdf

5. Choksi D, Kolhe KM, Ingle M, Rathi C, Khairnar H, Chauhan SG, et al. Esophageal carcinoma: an epidemiological analysis and study of the time trends over the last 20 years from a single center in India. J Family Med Prim Care. 2020;9(3): 1695-9. doi:10.4103/jfmpc.jfmpc_1111_19Ghosh B, Mathew A, Mullapally SK. Immunotherapy for cancer in India: navigating the access­efficacy chasm. Indian J Med Paediatr Oncol. 2026;47(4):323-5. doi:10.1055/s-0046-1824566.

6. Noronha V, Sekar A, Rajendra A, Mokal S, Patil V, Menon N, et al. Epidemiological trend of esophageal cancer at a tertiary cancer center in Mumbai, India, over the past 15 years. J Gastrointest Cancer. 2023;54:903-12. doi:10.1007/s12029-022-00887-z.

7. Wang ZX, Cui C, Yao J, Zhang Y, Li M, Feng J, et al. Toripalimab plus chemotherapy in treatment-naive, advanced esophageal squamous cell carcinoma (JUPITER-06): a multicenter phase 3 trial. Cancer Cell. 2022;40(3):277-88.e3. doi:10.1016/j.ccell.2022.02.007.

8. Chen YX, Jin Y, Chen YK, Cui C, Yao J, Zhang Y, et al. Final overall survival analysis and exploratory biomarker study from JUPITER-06: a randomized phase III trial of toripalimab plus chemotherapy in advanced esophageal squamous-cell carcinoma. Ann Oncol. 2026;37(7):986-98.

9. Ravindranathan S, Wang X, Chin DJ, Tseng SY, Klakamp S, Widmann K, et al. Characteristics of toripalimab: a next-generation anti-PD-1 antibody with potent T-cell activation and enhanced clinical efficacy irrespective of PD-L1 status. J Immunother Cancer. 2023; 11 (Suppl 1):A522.

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