Dr Reddy's Laboratories gets CDSCO Panel Nod To Import and Market Toripalimab 240mg solution for infusion
New Delhi: Noting an unmet medical need for recurrent locally advanced/metastatic nasopharyngeal carcinoma (RM-NPC) in India, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major Dr Reddy's Laboratories to import and market Toripalimab 240mg solution for infusion with a waiver of local Phase III clinical trial with the condition to conduct Phase IV clinical trial in India.
This came after Dr. Reddy's Laboratories presented the proposal for a grant of permission to import and market Toripalimab 240mg solution for infusion for the following indications:
1. In combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC).
2. As a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after platinum-containing chemotherapy with local Phase III clinical trial waiver.
The committee noted that the proposed drug Toripalimab was granted an orphan drug designation for the treatment of nasopharyngeal cancer by the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA) and approved in China and USA for the proposed indications based on Phase II and Phase III trials conducted.
The expert panel noted that there is an unmet medical need for recurrent locally advanced/metastatic nasopharyngeal carcinoma (RM-NPC) in India.
Toripalimab is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells. Toripalimab is a type of immunotherapy called an immune checkpoint inhibitor. It targets a protein called PD-1 on certain immune cells, allowing them to better attack and kill cancer cells.
At the recent SEC meeting for Oncology on 3rd and 4th April 2024, the expert panel reviewed the proposal for grant of permission to import and market Toripalimab 240mg solution for infusion presented by drug major Dr Reddy's Laboratories.
After detailed deliberation, the committee recommended a grant of permission to import and market Toripalimab 240mg solution for infusion with a waiver of local Phase III clinical trial with the condition of conducting Phase IV clinical trial in India.
Accordingly, the committee suggested that the Phase IV clinical trial protocol should be submitted by the firm within 3 months from the grant of marketing authorization.
