Dr Reddy’s launches India’s first immuno-oncology drug to treat rare form of head and neck cancer

Dr Reddy’s Laboratories on November 28 launched India’s first immuno-oncology drug, Toripalimab, to treat a rare form of cancer. The drug is approved for the treatment of nasopharyngeal carcinoma, a rare type of head and neck cancer.  

The Hyderabad-based company, in an exchange filing, said this is India’s first and only immuno-oncology drug approved by the US Food and Drug Administration, European Medicines Agency, Medicines and Healthcare Products Regulatory Agency, and others for the treatment of recurrent or metastatic nasopharyngeal carcinoma in adults. 

With this launch, India has become the third country in the world, after China and the US, to receive access to this next-generation PD-1 inhibitor. Dr Reddy’s will market the drug under the brand name ‘Zytorvi’ in India. The combination of Toripalimab and standard-of-care chemotherapy has shown a 48 percent reduction in the risk of progression or death through nasopharyngeal carcinoma. 

In 2023, Dr Reddy’s entered into a licence and commercialisation agreement with Shanghai Junshi Biosciences for Toripalimab, which gave it exclusive rights to develop and commercialise the drug in 21 countries, including India, South Africa, Brazil and various countries in Latin America. The agreement also allowed Dr Reddy’s to expand the scope of the licence to Australia, New Zealand and nine other countries.

Dr Reddy’s Laboratories Ltd reported a notable revenue increase of 16.5 percent in its Q2 FY25 results at Rs 8,016.2 crore, surpassing estimates. However, the company saw a 9.5 percent decline in profit, which stood at Rs 1,342 crore compared to Rs 1,482 crore in the previous year. EBITDA rose 3.5 percent to Rs 2,054.5 crore, though margins narrowed to 25.6 percent from 29 percent. The company has reiterated its FY25 guidance, with R&D expenses expected to remain at around 8.5 percent.  

What is Nasopharyngeal carcinoma?

Nasopharyngeal carcinoma is a rare form of head and neck cancer. However, the prognosis of the disease for patients in advanced stages is poor, and India is among the top five countries in the world in terms of disease burden. 

Nasopharyngeal carcinoma is a malignant tumour that arises from the epithelium of the nasopharynx. According to GLOBOCAN 2022 statistics, the number of newly diagnosed NPC cases in 2022 exceeded 120,000 worldwide. In India, there were 6,519 newly diagnosed cases of NPC in 2022, with Kohima in Nagaland having an incidence of 19.4/100,000 population.