FDA approved Tevimbra (tislelizumab-jsgr) for Esophageal and Gastric CancersFDA approved new drug Tevimbra for two types of stomach and esophagus cancer.

Tevimbra (tislelizumab-jsgr) is a programmed death receptor-1 (PD-1)-blocking antibody. It binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, thereby releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

Tevimbra is indicated for: - First-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1), in combination with platinum-containing chemotherapy. - Treatment of adults with unresectable or metastatic ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor, as a single agent. - First-line treatment of adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) whose tumors express PD-L1 (≥1), in combination with platinum and fluoropyrimidine-based chemotherapy.

Select patients based on PD-L1 expression in tumor specimens. An FDA-approved companion diagnostic is not available for either indication.

The recommended dosage of Tevimbra is 150 mg every 2 weeks, 200 mg every 3 weeks, 300 mg every 4 weeks, or 400 mg every 6 weeks, administered intravenously. For first-line ESCC, it is given in combination with platinum-containing chemotherapy; for G/GEJ, with platinum and fluoropyrimidine-based chemotherapy; for previously treated ESCC, as a single agent. Treatment continues until disease progression or unacceptable toxicity. No dose reduction is recommended. For adverse reactions, withhold for severe (Grade 3) immune-mediated reactions and permanently discontinue for life-threatening (Grade 4) reactions, recurrent severe Grade 3 reactions requiring systemic immunosuppression, or inability to reduce corticosteroid dose to 10 mg or less of prednisone equivalent per day within 12 weeks of initiating steroids. Specific dosage modifications for immune-mediated adverse reactions (e.g., pneumonitis, colitis, hepatitis) are provided in the label.

Trial data not available in label.

Warnings and precautions include immune-mediated adverse reactions such as pneumonitis, colitis, hepatitis, and others. Dosage modifications are required for these reactions. No contraindications are listed in the provided label text.

Tevimbra offers a new PD-1 inhibitor option for first-line treatment of PD-L1-positive ESCC and HER2-negative G/GEJ, and for previously treated ESCC. Its flexible dosing schedule may be convenient. However, the requirement for PD-L1 expression and the lack of a companion diagnostic may limit immediate use. Clinicians should weigh efficacy data (not detailed here) and safety profile when considering Tevimbra in treatment algorithms.