Initial US Approval:
2024
Key Clinical Studies:
eNRGy study (NCT02912949)
Drug Class/Description:
Bispecific HER2- and HER3-directed antibody
Indications and Usage:
- Adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.*
- Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.*
*This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Dosage Administration:
- Select patients for treatment with BIZENGRI based on the presence of an NRG1 gene fusion.
- Evaluate left ventricular ejection fraction (LVEF) before initiating BIZENGRI.
- The recommended dosage of BIZENGRI is 750 mg every 2 weeks until disease progression or unacceptable toxicity.
- Administer premedications before each infusion to reduce the risk of infusion-related reactions.
- Administer as an intravenous infusion, after dilution, over 4 hours
Dosage Forms and Strengths:
Injection: 375 mg/18.75 mL (20 mg/mL) in a single-dose vial.
Contraindications:
None.
Warnings and Precautions:
Infusion-Related Reactions (IRR)/Hypersensitivity/Anaphylactic Reactions: Administer BIZENGRI in a setting with emergency resuscitation equipment and staff who are trained to monitor for IRRs and to administer emergency medications. Monitor for signs and symptoms of IRR. Interrupt infusion in patients with ≤ Grade 3 IRRs and administer symptomatic treatment as needed. Resume infusion at a reduced rate after resolution of symptoms. Immediately stop the infusion and permanently discontinue BIZENGRI for Grade 4 or life-threatening IRR or hypersensitivity/anaphylaxis.
Interstitial Lung Disease (ILD)/Pneumonitis: Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Permanently discontinue BIZENGRI in patients with ≥ Grade 2 ILD/pneumonitis.
Left Ventricular Dysfunction: Assess LVEF before initiating BIZENGRI and at regular intervals during treatment as clinically indicated. Manage through treatment interruption or discontinuation. Permanently discontinue BIZENGRI in patients with symptomatic congestive heart failure (CHF).
Adverse Reactions:
- The most common adverse reactions (≥ 10%) in patients were diarrhea musculoskeletal pain, fatigue, nausea, infusion-related reactions (IRR), dyspnea, rash, constipation, vomiting, abdominal pain, and edema.
- The most common Grade 3 or 4 laboratory abnormalities (≥ 2%) were increased GGT, decreased hemoglobin, decreased sodium, decreased platelets, increased AST, increased ALT, increased alkaline phosphatase, decreased magnesium, decreased phosphate, increased aPTT and increased bilirubin.
Use in Specific Populations:
Females and Males of Reproductive Potential: Verify pregnancy status of females prior to initiation of BIZENGRI.
Adapted From:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761352s001lbl.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.
