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.