Telisotuzumab vedotin

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).

Telisotuzumab vedotin-tllv is a c-Met-directed antibody drug conjugate (ADC). The antibody is a humanized IgG1κ directed against c-Met, the cell surface receptor for hepatocyte growth factor. The small molecule, MMAE, is a microtubule-disrupting agent, attached to the antibody via a protease cleavable linker. Following binding to c-Met-expressing cells, telisotuzumab vedotin-tllv undergoes internalization and intracellular cleavage of MMAE. MMAE disrupts the microtubule network of actively dividing cells, subsequently inducing cell cycle arrest and apoptotic cell death. Telisotuzumab vedotin-tllv exhibited antitumor activity in xenograft models of NSCLC.

For intravenous infusion only. The recommended dosage of EMRELIS is 1.9 mg/kg administered intravenously every 2 weeks until disease progression or unacceptable toxicity. Reconstitute and further dilute EMRELIS prior to intravenous infusion.

None. None.

Peripheral Neuropathy: Monitor patients for new or worsening peripheral neuropathy. Withhold, reduce the dose, or permanently discontinue EMRELIS based on the severity. I nterstitial Lung Disease (ILD)/ Pneumonitis: Severe, life-threatening or fatal ILD/pneumonitis may occur. Withhold or permanently discontinue EMRELIS based on the severity. Ocular Surface Disorders: Monitor patients for signs or symptoms of ocular surface disorders, including vision changes. Infusion - Related Reactions (IRR): Monitor patients for IRR. Withhold, reduce the rate of infusion, or permanently discontinue EMRELIS based on the severity. For patients who experience IRR, administer premedications prior to subsequent infusions. Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients about the potential risk to a fetus and to use effective contraception.

The following clinically significant adverse reactions are described elsewhere in the labeling: Peripheral Neuropathy Interstitial Lung Disease (ILD)/Pneumonitis Ocular Surface Disorders Infusion-Related Reactions (IRR) 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.

S trong CYP3A I nhibitors: concomitant use with EMRELIS may increase the AUC of MMAE. Monitor for increased risk of adverse reactions to EMRELIS.

Store refrigerated at 2 o C to 8 o C (36 o F to 46 o F) in original carton to protect from light. Do not freeze. Do not shake.