Hyderabad : Dr. Reddy’s Laboratories has announced the launch of Toripalimab in India, a groundbreaking treatment for adults with nasopharyngeal carcinoma (NPC), a rare and aggressive form of cancer that originates in the upper part of the throat. NPC is known for its poor prognosis in advanced stages, and India ranks among the top five countries globally in terms of disease burden.
Toripalimab, an anti-PD-1 monoclonal antibody, works by blocking the interaction of PD-1 with its ligands, PD-L1 and PD-L2, enhancing the immune system’s ability to recognize and destroy tumor cells. In clinical trials, a combination of Toripalimab with standard chemotherapy has shown a 48% reduction in the risk of progression or death in patients with recurrent or metastatic NPC (RM-NPC).
A Significant Milestone for NPC Patients in India
M.V. Ramana, CEO of Branded Markets (India and Emerging Markets) at Dr. Reddy’s, emphasized the importance of this launch for Indian patients. “The launch of Toripalimab marks a significant milestone for NPC patients in India. Despite NPC being a rare form of head and neck cancer, the prognosis for advanced-stage cases is poor. With India having one of the highest burdens of this disease, Toripalimab offers new hope for patients,” said Ramana.
He further noted, “Toripalimab, as the next-generation PD-1 inhibitor, has demonstrated superior outcomes for recurrent or metastatic nasopharyngeal carcinoma compared to standard treatments, addressing a critical unmet need in India.”
Regulatory Approval and Treatment Advancements
The launch follows approval by the Central Drugs Standard Control Organisation (CDSCO) in April, which granted Dr. Reddy’s Laboratories permission to import and market Toripalimab in India under the brand name Zytorvi. This approval positions Toripalimab as an important addition to the therapeutic options available for NPC in the country.
Prior to Toripalimab’s approval, the standard treatment for RM-NPC in India involved chemotherapy with gemcitabine and cisplatin. Toripalimab is now indicated as the first-line treatment for adults with metastatic or recurrent locally advanced NPC, in combination with these chemotherapy agents.
NPC: A Rare but Growing Threat in India
Nasopharyngeal carcinoma is a malignant tumor that develops in the nasopharynx, the part of the throat located behind the nose. According to GLOBOCAN 2022, more than 120,000 new cases of NPC were diagnosed worldwide in 2022. In India, there were 6,519 new cases of NPC reported that year, with the northeastern region of Kohima in Nagaland recording one of the highest incidences at 19.4 cases per 100,000 population.
A Global First for Toripalimab
Toripalimab has already earned recognition as the first immuno-oncology drug approved by major regulatory bodies, including the US Food and Drug Administration (USFDA), the European Medicines Agency (EMA), and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of recurrent or metastatic nasopharyngeal carcinoma in adults.
The launch of Toripalimab offers a significant breakthrough in the treatment of NPC, providing patients in India with a potentially life-saving option for a condition that previously had limited therapeutic alternatives.