Glenmark Pharmaceutical Gets CDSCO Panel Nod To Import and Market Anti-cancer Drug Tislelizumab

New Delhi: Drug major Glenmark Pharmaceutical has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to import and market the anti-cancer drug Tislelizumab Injection 100mg (10ml)/Vial with waiver of local clinical trials.

This came after the firm presented the safety and efficacy data of 28 Indian patients with non-small cell lung cancer (NSCLC) and head neck squamous cell cancer (HNSCC) participated in the Global Clinical Trial (GCT).

However, this approval is subject to a condition to conduct a Phase IV clinical trial in India for both the proposed indications.

Tislelizumab is an IgG4 variant monoclonal antibody against PD-1 indicated for the treatment of unresectable, locally advanced or metastatic esophageal squamous cell carcinoma.

Tislelizumab is a humanized monoclonal IgG4 antibody against programmed death receptor-1 (PD-1). It was engineered to have a nullified Fc portion, thus minimizing binding to FcγR on macrophages and limiting treatment resistance via antibody-dependent phagocytosis. By blocking PD-L1/PD-L2–mediated cell signaling, tislelizumab restores T-cell function through cytokine production, resulting in immune-mediated antitumor responses. Tislelizumab is generally well tolerated with manageable and mild-to-moderate adverse effects.

At the recent SEC meeting for oncology held on January 16, 2025, the expert panel reviewed the safety and efficacy data of 28 Indian patients in non-small cell lung cancer (NSCLC) and head neck squamous cell cancer (HNSCC) participated in the Global Clinical Trial (GCT).

The Committee noted that the drug is approved in the USA, Europe, the United Kingdom, Australia, China, and other countries. The expert panel further noted that the proposed indications come under the category of orphan drugs, and there is an unmet medical need in the country.

After detailed deliberation, the committee recommended the grant of permission to import and market the drug with waiver of local clinical trials with the condition to conduct Phase IV clinical trials in India for both the proposed indications.

Accordingly, the expert panel suggested that the firm submit the Phase IV Clinical Trial protocol to CDSCO within 3 months of the grant of marketing authorization.

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