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SEC recommends approval to Dr Reddy's to import and market anti-cancer drug toripalimab
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Gireesh Babu, New Delhi
April 19 , 2024
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The Subject Expert Committee (SEC), that advises the Central drug regulator regarding clinical trials and approvals of drugs, has recommended for grant of permission to Dr Reddy's Laboratories to import and market cancer drug toripalimab 240 mg solution for infusion with waiver of local phase III clinical trial, subject to conditions.
The company submitted its proposal earlier for grant of permission to import and market toripalimab 240 mg solution for infusion for two indications - the drug in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC), and as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy with local phase III clinical trial waiver.
The SEC for oncology, in a meeting earlier this month, noted that the proposed drug was granted an orphan drug designation for the treatment of nasopharyngeal cancer by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). It was also approved in China and US for the proposed indications based on phase II and phase III trials conducted.
"There is an unmet medical need for recurrent locally advanced/metastatic nasopharyngeal carcinoma (RM-NPC) in India," it said.
The Committee considered the proposal and recommended for grant of permission to import and market the drug with waiver of local phase III clinical trial with condition to conduct phase IV clinical trial in India. Accordingly, phase IV clinical trial protocol should be submitted by the firm within three months from grant of marketing authorisation, it added.
It may be noted that Dr Reddy's Laboratories has entered into a collaboration with Shanghai Junshi Biosciences Co. Ltd, a China-based company last year to develop and commercialise toripalimab, the anti-PD-1 monoclonal antibody in Latin America, India, South Africa, among others.
In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing under the brand name Tuoyi.
In China, it has been approved for six indications including unresectable or metastatic melanoma after failure of standard systemic therapy; recurrent or metastatic NPC after failure of at least two lines of prior systemic therapy; locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy; in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC; and others.
Junshi Biosciences announced in May, 2023, that under the license and commercialization agreement, the company will grant a licence to Dr. Reddy’s to develop and exclusively commercialise toripalimab in Brazil, Mexico, Colombia, Argentina, Peru, Chile, Panama, Uruguay, India and South Africa. Dr. Reddy’s may elect to expand the scope of the license to cover Australia, New Zealand and nine other countries.
Under the terms of the agreement, Junshi Biosciences also granted Dr. Reddy’s the exclusive right of first negotiation for commercialisation, in the event that Junshi Biosciences determines to grant any third party the rights to commercialize two other products as agreed in the agreement in one or more countries within the total 21 countries of Dr. Reddy’s territory.
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumour cells, said Junshi Biosciences.
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