On October 17, 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) endorsed two new therapeutic indications for Tevimbra (tislelizumab), expanding its use for adult patients with specific types of oesophageal and gastric cancers.

Oesophageal Squamous Cell Carcinoma (OSCC)

Tevimbra, when combined with platinum-based chemotherapy, has been recommended as a first-line treatment for adult patients with unresectable, locally advanced, or metastatic OSCC whose tumours express the biomarker PD‑L1 at a level of 5% or higher. PD-L1 is a protein that some cancer cells use to protect themselves from the immune system. When cancer cells have PD-L1 on their surface, it acts like a shield, stopping T cells (a type of immune cell) from attacking them. This helps the cancer survive and grow, as it can avoid being destroyed by the body’s natural defenses. This biomarker, measured by the tumour area positivity (TAP) score, helps in identifying patients who may benefit most from Tevimbra’s targeted approach.

Gastric and Gastroesophageal Junction (G/GEJ) Adenocarcinoma

For patients with HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, Tevimbra has been recommended for use alongside platinum and fluoropyrimidine-based chemotherapy as a first-line treatment. HER2 is a protein that can help cancer cells grow quickly; if a tumour is “HER2-negative,” it means it does not have an excess of this protein. To qualify for Tevimbra, patients’ tumours must also express PD-L1, a protein that helps some cancer cells avoid immune attacks, with a TAP score of 5% or higher.

These recent updates underline Tevimbra’s growing role in treating digestive cancers, where tailored therapies continue to provide promising outcomes. The new indications represent an important step in offering patients with advanced oesophageal and gastric cancers additional therapeutic options.

These recommendations by CHMP await a final decision by the European Commission, typically expected within 67 days.

Tevimbra’s Other Approved Indications

Tevimbra is already approved for several other cancer types across Europe, including non-small cell lung cancer (NSCLC) and other forms of oesophageal squamous cell carcinoma. Its indications now cover a broad range of advanced cancers, with a particular focus on those that express PD‑L1, a protein associated with better responses to immune-based therapies.

The updated product information will soon be available in multiple EU languages, providing more comprehensive guidance for healthcare providers and patients.

Author:
Natasha Muench