Pharmacy Bulletin

Pharmacy Bulletin

We share important prescription drug information to help you stay informed about updates concerning particular prescription medicines.

VativoRx Bottle update

Tevimbra Approved for Esophageal Cancer

The U.S. Food and Drug Administration (FDA) approved Tevimbra® (tislelizumab-jsgr) injection on March 13, 2024. It is an immunoglobulin G4 (IgG4) programmed cell death protein 1 (PD-1) inhibitor that is indicated as second-line monotherapy after chemotherapy (chemo) for adults who have inoperable or metastatic esophageal squamous cell carcinoma (ESCC). The patient must not have been treated previously with a PD-1 inhibitor or a programmed death-ligand 1 (PD-L1) inhibitor. The recommended dose is 200mg given as an intravenous (IV) infusion once every 21 days. BeiGene intends to launch Tevimbra in the second half of 2024. Its cost has not yet been announced. Look here for full prescribing information.

At a Glance

  • Brand (Generic) Name: Tevimbra (tislelizumab-jsgr)
  • Manufacturer: BeiGene
  • Date Approved: March 13, 2024
  • Indication: to treat adults who have unresectable or metastatic ESCC after prior systemic chemo that did not include a PD-(L)1 inhibitor
  • Dosage Forms Available: single-dose vials of 100mg/10mL
  • Launch Date: H2:2024
  • Estimated Cost: Not yet made public
  • The American Cancer Society (ACS) projects that 22,000 patients will be diagnosed with some type of esophageal cancer in 2024. About one-third of cases are ESCC.
  • The five-year survival rate for esophageal cancer that has metastasized is only around 6%
  • Tevimbra blocks PD-1 to enhance immune response.
  • After six months of treatment in a pivotal clinical trial, overall survival (OS) rates were 62.3% for patients using Tevimbra vs. 51.8% for study participants given chemo. At 12 months, OS was 37.4% vs 23.7%, respectively.
  • Common side effects among clinical trial participants were cough, elevated blood sugar, fatigue, and increased liver enzymes. Significant percentages of patients who were treated with Tevimbra also experienced decreases in some blood components, resulting in anemia for some.
  • Early and mid-stages of ESCC can be treated with surgery, radiation, and/or drug therapy. Various chemo regimens are indicated for esophageal cancer, as are targeted drugs, such as Yervoy® (ipilimumab), and PD-1/PD-L1 inhibitors, such as Opdivo® (nivolumab). For advanced cases with specific genetic mutations, drug combinations, including a targeted kinase inhibitor, such as Vitrakvi® (larotrectinib) capsules, may be used.