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IMPORTANT SAFETY INFORMATION
Peripheral Neuropathy
EMRELIS can cause peripheral neuropathy, including peripheral sensory neuropathy and peripheral motor neuropathy. In the safety population, peripheral neuropathy occurred in 51% of patients treated with EMRELIS, including Grade 3 in 11%. These adverse reactions included peripheral sensory neuropathy in 45% of patients and peripheral motor neuropathy in 9%. The median time to onset of peripheral neuropathy was 105 days (range: 1 to 472 days). Peripheral neuropathy led to permanent discontinuation of EMRELIS in 13% of patients. The median time to onset of peripheral neuropathy leading to treatment discontinuation was 249 days (range: 57 to 519 days). Of the 7 patients with motor neuropathy ongoing as of their last dose of EMRELIS, 6 had persistent Grade 1 or 2 symptoms 30 days after their last dose.
Monitor patients for signs and symptoms of new or worsening peripheral neuropathy such as hypoesthesia, hyperesthesia, paresthesia, a burning sensation, neuropathic pain, or muscle weakness. Withhold, reduce the dose, or permanently discontinue EMRELIS based on severity.
Interstitial Lung Disease/Pneumonitis
EMRELIS can cause severe, life-threatening, or fatal interstitial lung disease (ILD)/pneumonitis. In the safety population, ILD/pneumonitis occurred in 10% of patients treated with EMRELIS, including Grade 3 in 3% and Grade 4 in 0.6%. There were 3 fatal cases of ILD/pneumonitis in patients who received EMRELIS. The median time to onset of ILD/pneumonitis was 48 days (range: 23 to 85 days). ILD/pneumonitis led to permanent discontinuation of EMRELIS in 7% of patients. The median time to onset of ILD/pneumonitis leading to treatment discontinuation was 46 days (range: 23 to 85 days).
Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD/pneumonitis. Withhold or permanently discontinue EMRELIS based on severity.
Ocular Surface Disorders
EMRELIS can cause ocular surface disorders, including blurred vision, visual impairment, keratitis, and dry eye. In the safety population, ocular surface disorders occurred in 25% of patients treated with EMRELIS. The most common ocular surface disorders were blurred vision (15%), keratitis (11%), and dry eye (5%). Grade 3 ocular surface disorders occurred in 1.2% of patients [blurred vision (1.2%), and keratitis (0.6%)]. The median time to onset of ocular surface disorders was 47 days (range: 1 to 319 days).
Monitor patients for ocular surface disorders during treatment with EMRELIS. Withhold EMRELIS and refer patients to an eye care professional for an ophthalmic examination and treatment for patients who develop Grade ≥2 ocular toxicity. Withhold or permanently discontinue EMRELIS based on severity.
Infusion-Related Reactions
EMRELIS can cause infusion-related reactions (IRR); signs and symptoms of IRR include dyspnea, flushing, chills, nausea, chest discomfort, and hypotension. The median time to onset of IRR was 28 days (range: 1 to 43 days). In the safety population, IRR occurred in 3% of patients treated with EMRELIS, including Grade 3 in 1.2% and Grade 4 in 0.6%. IRR led to permanent discontinuation of EMRELIS in 0.6% of patients.
Monitor patients for signs and symptoms of infusion reactions during EMRELIS infusion. Withhold, reduce the rate of infusion, or permanently discontinue EMRELIS based on severity. For patients who experience IRR, administer premedications prior to subsequent infusions.
Embryo-Fetal Toxicity
Based on the mechanism of action and findings in animals, EMRELIS can cause fetal harm when administered to a pregnant woman. The small molecule component of EMRELIS, monomethyl auristatin E (MMAE), administered to rats caused adverse developmental outcomes, including embryo-fetal mortality and structural abnormalities, at exposures similar to those occurring clinically at the recommended dose.
Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with EMRELIS and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with EMRELIS and for 4 months after the last dose.
Adverse Reactions
Serious adverse reactions occurred in 35% of patients. The most common adverse reactions (≥20%) were peripheral neuropathy, fatigue, decreased appetite, and peripheral edema.
The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin, and decreased calcium.
Drug Interactions
Strong CYP3A Inhibitors: Concomitant use with EMRELIS may increase the area under the curve of MMAE. Monitor for increased risk of adverse reactions to EMRELIS.
Use in Specific Populations
Severe or Moderate Hepatic Impairment: Avoid the use of EMRELIS.
Lactation: Advise lactating women not to breastfeed during treatment with EMRELIS and for 1 month after the last dose.
Infertility: Based on findings from animal studies, EMRELIS may impair fertility in females and males.
INDICATION
EMRELIS is indicated for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.
This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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REFERENCES:
1. EMRELIS [package insert]. North Chicago, IL: AbbVie Inc.; 2025. 2. Camidge DR, Bar J, Horinouchi H, et al. Telisotuzumab vedotin monotherapy in patients with previously treated c-Met protein‒overexpressing advanced nonsquamous EGFR-wildtype non‒small cell lung cancer in the Phase II LUMINOSITY Trial. J Clin Oncol. 2024;42(25):3000-3011. 3. Roche Diagnostics. VENTANA MET (SP44) RxDx Assay Method Sheet. Roche; 2025. 4. Van Der Steen N, Zwaenepoel K, Mazzaschi G, et al. The role of c-Met as a biomarker and player in innate and acquired resistance in non-small-cell lung cancer: two new mutations warrant further studies. Molecules. 2019;24(24):4443. 5. Pawelczyk K, Piotrowska A, Ciesielska U, et al. Role of PD-L1 expression in non-small cell lung cancer and their prognostic significance according to clinicopathological factors and diagnostic markers. Int J Mol Sci. 2019;20(4):824. 6. Mino-Kenudson M. Immunohistochemistry for predictive biomarkers in non-small cell lung cancer. Transl Lung Cancer Res. 2017;6(5):570-587. 7. Bar J, Cai MH, Choi YC, et al. Prevalence, molecular characterization, and prognosis of MET‒overexpressing non-small cell lung cancer (NSCLC) in a real-world patient cohort. Ann Oncol. 2023;34(S2):S799-S800. 8. Le X, Aggarwal C, Simmons A, et al. METPRO: Evaluating prognostic value of c-Met protein overexpression and concurrent biomarker presence. Ann Oncol. 2024;35(S2):S829. 9. Liang H, Wang M. MET oncogene in non-small cell lung cancer: mechanism of MET dysregulation and agents targeting the HGF/c-Met axis. Onco Targets Ther. 2020;13:2491-2510. 10. Cortot AB, Dubois R, Gregoire V, et al. Consistency analysis of c-Met protein expression over time in patients with non-squamous non-small cell lung cancer. Ann Oncol. 2024;35(S2):S282. 11. Yan M, Schwaederle M, Arguello D, Millis SZ, Gatalica Z, Kurzrock R. HER2 expression status in diverse cancers: review of results from 37,992 patients. Cancer Metastasis Rev. 2015;34(1):157-164. 12. Zinner RG, Glisson BS, Fossella FV, et al. Trastuzumab in combination with cisplatin and gemcitabine in patients with Her2-overexpressing, untreated, advanced non-small cell lung cancer: report of a phase II trial and findings regarding optimal identification of patients with Her2-overexpressing disease. Lung Cancer. 2004;44(1):99-110. 13. Thai AA, Soloman BJ, Sequist LV, Gainor JF, Heist RS. Lung cancer. Lancet. 2021;398(10299):535-554. 14. Ma PC, Jagadeeswaran R, Jagadeesh S, et al. Functional expression and mutations of c-Met and its therapeutic inhibition with SU11274 and small interfering RNA in non‒small cell lung cancer. Cancer Res. 2005;65(4):1479-1488. 15. Gogia P, Ashraf H, Bhasin S, Xu Y. Antibody‒drug conjugates: a review of approved drugs and their clinical level of evidence. Cancers (Basel). 2023;15(15):3886. 16. Data on file, ABVRRTI80479. AbbVie, Inc. 17. Tsao MS, Yatabe Y. Old soldiers never die: is there still a role for immunohistochemistry in the era of next-generation sequencing panel testing? J Thorac Oncol. 2019;14(12):2035-2038.
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