Initial US Approval:
2024
Key Clinical Studies:
RATIONALE-302 (NCT03430843); RATIONALE-305 (NCT03777657)
Drug Class/Description:
Programmed death receptor-1 (PD-1) blocking antibody
Indications and Usage:
Esophageal Cancer
- As a single agent in adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
Gastric Cancer
- In combination with platinum and fluoropyrimidine-based chemotherapy in adults for the first line treatment of unresectable or metastatic HER2- negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L
Dosage Administration:
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.
Dosage Forms and Strengths:
Injection: 100 mg/10 mL solution in a single-dose vial.
Contraindications:
None.
Warnings and Precautions:
- Immune-Mediated Adverse Reactions:
- Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune-mediated dermatologic adverse reactions, and solid organ transplant rejection.
- Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
- Withhold or permanently discontinue TEVIMBRA based on the severity of reaction.
- Infusion-Related Reactions: Slow the rate of infusion, interrupt, or permanently discontinue based on severity of infusion reaction.
- Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT): Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody.
- Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use of effective contraception.
Adverse Reactions:
- The most common adverse reactions (≥20%) of TEVIMBRA as a single agent, including laboratory abnormalities with TEVIMBRA were: increased glucose, decreased hemoglobin, decreased lymphocytes, decreased sodium, decreased albumin, increased alkaline phosphatase, anemia, fatigue, increased AST, musculoskeletal pain, decreased weight, increased ALT, and cough.
- The most common adverse reactions (≥20%), including laboratory abnormalities of TEVIMBRA in combination with platinum and fluoropyrimidine-based chemotherapy: nausea, fatigue, decreased appetite, anemia, peripheral sensory neuropathy, vomiting, decreased platelet count , decreased neutrophil count, increased aspartate aminotransferase, diarrhea, abdominal pain, increased alanine aminotransferase, decreased white blood cell count, decreased weight, and pyrexia.
Use in Specific Populations:
- Lactation: Advise not to breastfeed.
Adapted From:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761417s000lbl.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
