Dr Reddy’s Laboratories announced on Wednesday that it has obtained regulatory clearance from the Drugs Controller General of India (DCGI) for Zytorvi (toripalimab).
In an exchange filing issued on Wednesday, October 21, the company said it entered into a licensing and commercialisation agreement with Junshi Biosciences in 2023 for toripalimab across 21 countries.
Zytorvi (toripalimab) is a therapeutic agent designed to broaden patient access to first-line immunotherapy for individuals suffering from advanced oesophageal squamous cell carcinoma (ESCC) throughout India.
The pharmaceutical company disclosed in an official statement that the drug has received approval for use in combination with cisplatin and paclitaxel as a first-line treatment option for adult patients presenting with unresectable advanced, recurrent, or metastatic ESCC.
What Is Zytorvi (toripalimab)?
This regulatory approval represents Zytorvi’s second authorised therapeutic indication within the country, demonstrating expansion beyond its previously approved use in nasopharyngeal carcinoma.
According to the company’s statement, ESCC constitutes approximately 80% of all oesophagal cancer cases documented in India.
Zytorvi is formulated with toripalimab, a monoclonal antibody that functions by binding to PD-1 and inhibiting its interaction with PD-L1 and PD-L2, thereby facilitating enhanced T-cell activity directed against malignant cells.
During the concluding overall-survival analysis, the median overall survival duration was documented at 17.7 months for patients receiving toripalimab combined with chemotherapy, compared with 12.9 months for those receiving chemotherapy as monotherapy, the statement further indicated.
Stock Performance
The shares of Dr Reddy’s Lab have largely been volatile; the stock has slumped 0.38% or ₹4.70. The stock has fallen nearly 4% in the past year of trading. The current stock price is now down to ₹1,237.80 per share.
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