New FDA Approval: TEVIMBRA™ Summary

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The Food and Drug Administration (FDA) has approved tislelizumab-jsgr (TEVIMBRA™) for single-agent use in adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) following prior systemic chemotherapy that did not include a PD-1/PD-L1 inhibitor. The approval is based on the results of the RATIONALE 302 study (NCT03430843), which met its primary end point in the intention-to-treat (ITT) population with a statistically significant and clinically meaningful survival benefit shown for treatment with tislelizumab-jsgr vs chemotherapy.

Check out InpharmD's summary below:

Drug Name	TEVIMBRA™ (tislelizumab-jsgr)
Active Ingredient	tislelizumab
Date of Approval	3/13/2024
Manufacturer	BeiGene
Approval Pathways and Indications	BLA Indicated for the treatment of advanced or metastatic esophageal squamous cell carcinoma after prior chemotherapy
Therapeutic Class	Antineoplastic Agent; Anti-PD-1 Monoclonal Antibody
Formulation	Injection
MoA	Binding of the PD-1 ligands PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Tislelizumab-jsgr binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway- mediated inhibition of the immune response, including the anti-tumor immune response. Tislelizumab-jsgr decreased tumor growth in xenograft models and a human PD-1 transgenic mouse model.
Dosing and Administration	100 mg/10 mL (10 mg/mL) solution in a single-dose vial. Recommended Dosage: 200 mg as an intravenous infusion once every 3 weeks. Administer the first infusion over 60 minutes. If tolerated, subsequent infusions may be administered over 30 minutes.
Place in Therapy	TEVIMBRA™ was approved as a second-line treatment option, with results showing a statistically significant improvement in overall survival versus the investigator’s choice of chemotherapy. BeiGene is also proposing Tislelizumab as a first-line treatment option for unresectable, recurrent locally advanced or metastatic ESCC, and for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. The FDA is currently reviewing these applications and is expected to release its decisions in July and December 2024, respectively.
Expected Market Launch Date	Second half of 2024
New Molecular Entity (NME) or Existing Formulation	NME
Expected Cost	Unavailable
Product Discontinuation	N/A

 

Resources:

BeiGene’s Tevimbra Wins First US Approval Following Tough Regulatory Path. BioSpace. Accessed March 20, 2024. https://www.biospace.com/article/beigene-s-tevimbra-wins-first-u-s-approval-following-tough-regulatory-path-/#:~:text=The%20FDA

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