Glenmark Pharmaceuticals Ltd, a research-led, global pharmaceutical company has launched Tevimbra (tislelizumab) to offer immuno-oncology treatment for lung and esophageal cancer in India following approval by the Central Drugs Standard Control Organization (CDSCO).
Tevimbra is a uniquely designed anti-PD-1 monoclonal antibody developed by BeiGene (now BeOne Medicines), a global oncology leader committed to delivering advanced treatments for cancer patients worldwide. It is indicated for the treatment of first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) in combination with chemotherapy and second-line treatment of locally advanced or metastatic NSCLC and esophageal squamous cell carcinoma (ESCC) as monotherapy.
This launch marks Glenmark’s first foray into immune-oncology in India and is a major milestone in expanding its innovative oncology portfolio. NSCLC is the most common type of lung cancer, representing over 80% of all lung cancer cases. Similarly, ESCC is the most common histological subtype of esophageal cancer in India. Tevimbra caters to the needs of this significant patient population by offering a differentiated and proven treatment option for these cancers.
Tevimbra is approved and marketed in multiple leading global markets including the United States, European Union, Australia and China. Designed to selectively bind to PD-1 receptors, Tevimbra restores T-cell function while minimizing off-target immune suppression and has demonstrated robust efficacy with a favourable safety profile across diverse solid tumour types in multiple pivotal phase 3 studies and through a comprehensive global clinical development programme.
“With the launch of Tevimbra, Glenmark is delivering on its commitment to transform cancer care in India by making globally benchmarked immunotherapies more accessible,” said Alok Malik, president and business head – India formulations, Glenmark Pharmaceuticals Ltd.
“At a time when the cancer burden is rising sharply, we are proud to enable oncologists and patients to access Tevimbra, a therapy with proven efficacy and safety outcomes, strong science, and meaningful impact. Immuno-oncology offers a promising future for the treatment of various types of advanced cancers which are difficult to treat. Our foray in this area marks a significant inflection point in our journey to build a world-class oncology portfolio that is innovative, inclusive and at the same time life-changing for patients. We would like to acknowledge BeiGene (now BeOne Medicines) and Pi Health for their studies on tislelizumab,” Malik added.
Tevimbra is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1(PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fc?) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumours.
Tevimbra is the foundational asset of BeiGene (now BeOne Medicines) solid tumour portfolio and has shown potential across multiple tumour types and disease settings. The global Tevimbra clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including 21 registration-enabling studies. Tevimbra is approved in 46 countries, and more than 1.5 million patients have been treated globally.
Glenmark Pharmaceuticals Ltd. is a research-led, global pharmaceutical company, having a presence across Branded, generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 11 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries. |