Dr. Reddy’s has launched Toripalimab in India: Advancing Treatment for Nasopharyngeal Carcinoma

Reddy’s Laboratories Ltd. has announced the launch of Toripalimab, the first and only immuno-oncology drug approved for the treatment of recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) in India.

Toripalimab, a New Biological Entity (NBE), is the only PD-1 inhibitor approved by major global regulatory bodies, including the USFDA, EMA, MHRA, and NMPA, for treating adult patients with RM-NPC.

This launch positions India as the third country globally—following China and the United States—to have access to Toripalimab, a next-generation immunotherapy.

In 2023, Dr. Reddy’s entered into a licensing agreement with Shanghai Junshi Biosciences Co. Ltd., gaining exclusive rights to develop and commercialize Toripalimab in 21 countries, including India, South Africa, Brazil, and several Latin American countries.

Toripalimab represents a significant leap forward in treating nasopharyngeal carcinoma, a rare and aggressive form of head and neck cancer.

In India, NPC is particularly prevalent in the northeastern states, with over 6,500 new cases reported in 2022.

Traditionally, the standard treatment for RM-NPC has been chemotherapy, typically a combination of gemcitabine and cisplatin, which, while effective, often leads to significant side effects and limited outcomes in advanced disease stages.

Clinical trials have shown that Toripalimab, when combined with chemotherapy, results in a 48% reduction in the risk of progression or death for patients with RM-NPC.

Toripalimab works by inhibiting the PD-1 pathway, which tumors use to evade detection by the immune system. By blocking this pathway, Toripalimab enables the immune system to recognize and attack cancer cells more effectively.

In addition to its role in combination therapy, Toripalimab has also been approved as a monotherapy for patients with recurrent, unresectable, or metastatic NPC whose disease has progressed following platinum-based chemotherapy.

This makes Toripalimab a vital treatment option for patients in India, where access to newer cancer therapies has historically been limited.

M.V. Ramana, CEO of Branded Markets (India and Emerging Markets) at Dr. Reddy’s, expressed, “The launch of Toripalimab in India is a landmark moment for NPC patients in the country. NPC is a significant health challenge in India, and the prognosis for advanced stages of the disease has been poor.

Toripalimab offers an innovative treatment option that has demonstrated superior outcomes compared to the current standard of care. With India now being the third country in the world to offer this next-generation PD-1 inhibitor, we are proud to bring this life-changing therapy to patients who need it the most.”

Dr. Reddy’s has long been committed to improving cancer care in emerging markets, and the launch of Toripalimab is a major milestone in the company’s oncology portfolio.

As part of its broader commitment to global oncology, Dr. Reddy’s has been focused on expanding access to cutting-edge therapies in markets where there is significant unmet need.

Beyond providing new treatments, Dr. Reddy’s is also committed to supporting patients through initiatives that provide comprehensive cancer care, including nutritional support, digital tools, and patient education.

Toripalimab is not only an important therapeutic advance for NPC patients in India but also part of Dr. Reddy’s broader strategy to offer access to novel molecules through strategic collaborations.

The company’s oncology portfolio includes both innovative drugs like Toripalimab and a range of established cancer treatments, including biosimilars and generic cancer therapies, aiming to provide a holistic approach to cancer care.

Nasopharyngeal carcinoma (NPC) is a malignant tumor that originates in the nasopharynx, and it remains a significant public health challenge in India, where GLOBOCAN 2022 reported more than 120,000 new NPC cases globally.

NPC is particularly prevalent in India’s northeastern states, with Kohima in Nagaland having an age-adjusted rate of 19.4/100,000 population. As one of the countries with the highest burden of NPC, India urgently needs access to more effective treatments like Toripalimab.

In conclusion, the launch of Toripalimab in India marks a significant step forward in the fight against nasopharyngeal carcinoma, offering hope to patients who have had limited treatment options.

With the support of strategic collaborations and a commitment to improving cancer care, Dr. Reddy’s continues to make a meaningful impact on healthcare in India and beyond.

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