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Understanding NTRK Fusion Positive Metastatic Nsclc
NTRK fusion positive metastatic non-small cell lung cancer (NSCLC) is a type of lung cancer characterized by genetic alterations known as NTRK fusions. These fusions lead to the production of abnormal proteins that can drive cancer growth and spread.
1. Characteristics
- Genetic Basis: NTRK fusions involve the rearrangement of neurotrophic receptor tyrosine kinase (NTRK) genes.
- Metastatic Nature: The cancer has spread beyond the lungs to other parts of the body.
2. Diagnosis
- Genetic Testing: Identifying NTRK fusions requires specialized molecular testing.
3. Treatment Options
- Targeted Therapies: These are designed to specifically inhibit the activity of the abnormal proteins caused by NTRK fusions.
- Chemotherapy and Immunotherapy: Other treatments may be used depending on the patient's overall health and specific cancer characteristics.
What is ZEPZELCA® (lurbinectedin)
- ZEPZELCA® (lurbinectedin) is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
- 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).
Answers to frequently asked questions about ZEPZELCA® (lurbinectedin)
1. When was ZEPZELCA approved by the FDA?
- The FDA granted accelerated approval to ZEPZELCA® (lurbinectedin) on June 15, 2020.
- ZEPZELCA is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
- 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).
2. What is the mechanism of action (MOA) of ZEPZELCA?
- ZEPZELCA is an alkylating agent that binds to guanine residues in the minor groove of DNA, forming adducts and resulting in a bending of the DNA helix towards the major groove.
- Adduct formation triggers a cascade of events that can affect the subsequent activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in perturbation of the cell cycle and eventual cell death.
- ZEPZELCA was also shown to inhibit human monocyte activity in vitro and to reduce macrophage infiltration in implanted tumors in mice.
3. What are the drug interactions for ZEPZELCA?
- Strong and moderate CYP3A inhibitors: avoid coadministration with a strong or a moderate CYP3A inhibitor (including grapefruit and Seville oranges) as this increases lurbinectedin systemic exposure which may increase the incidence and severity of adverse reactions to ZEPZELCA. If the coadministration of ZEPZELCA cannot be avoided, reduce the dose of ZEPZELCA as appropriate.
- Strong CYP3A inducers: Avoid coadministration with a strong CYP3A inducer as it may decrease systemic exposure to lurbinectedin, which may decrease the efficacy of ZEPZELCA.
4. How do I order ZEPZELCA for my patient(s)?
- ZEPZELCA is available for purchase from the authorized Specialty Distributors and group purchasing organizations.
5. What is the dosage of ZEPZELCA?
- The recommended dose of ZEPZELCA is 3.2 mg/m(2) by intravenous infusion over 60 minutes, repeated every 21 days until disease progression or unacceptable toxicity.
- Initiate treatment with ZEPZELCA only if absolute neutrophil count (ANC) is ≥1,500 cells/mm(3) and platelet count is ≥100,000/mm(3).
Conclusion
In conclusion, Ntrk fusion-positive metastatic Nsclc is a challenging disease that requires a personalized approach to treatment, and therapies such as Lurbinectedin offer new hope for patients with this rare form of lung cancer. If you or a loved one has been diagnosed with Ntrk fusion-positive metastatic Nsclc, it is important to discuss all available treatment options, including the potential benefits of Lurbinectedin, with your healthcare team. By being informed and proactive in your treatment decisions, you can improve your chances for better outcomes and a higher quality of life.