Emrelis

Emrelis is used to treat non-squamous non-small cell lung cancer (NSCLC) in adults:

• that has spread to areas near the lungs (locally advanced) or other parts of the body (metastatic), and
• whose tumors have high c-Met protein overexpression, and
• who have received prior treatment.

Emrelis is administered as an intravenous infusion over 30 minutes every 2 weeks by a healthcare provider.

Emrelis (telisotuzumab vedotin-tllv) gained FDA approval on May 14, 2025. There is no generic or biosimilar.

• This approval is under the accelerated approval designation based on overall response rate (ORR) and duration of response (DOR). Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Emrelis (telisotuzumab vedotin-tllv) is an antibody-drug conjugate with a mechanism that fights cancer in a targeted way, minimizing damage to healthy cells. It consists of 2 parts:

• The targeting part (antibody) that finds cancer cells with a specific marker called c-Met
• A killing part (MMAE) that destroys cancer cells.

The antibody part attaches to c-Met markers on cancer cells, and then the drug gets pulled inside the cancer cell. Once inside the cancer cell, the killing part (MMAE) gets released. MMAE attacks the cell's internal structure (microtubules) needed for cell division, which stops cancer cells from dividing and causes them to die.

Before receiving Emrelis, tell your healthcare provider about all of your medical conditions, including if you:

• have a history of nerve problems
• have lung or breathing problems other than your lung cancer
• have eye problems
• have liver problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Emrelis can harm your unborn baby. Females who can become pregnant:

• Your healthcare provider should do a pregnancy test before you start treatment with Emrelis
• You should use effective birth control (contraception) during treatment and for 2 months after your last dose of Emrelis.

Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with Emrelis.

Males with female partners who can become pregnant:

• You should use an effective birth control during treatment and for 4 months after your last dose of Emrelis.

Breastfeeding

It is not known if Emrelis passes into your breast milk. Do not breastfeed during treatment with Emrelis and for 1 month after the last dose.

The most common side effects of Emrelis are:

• feeling tired
• decreased appetite
• swelling in the feet, ankles, legs, or hands

The most common severe abnormal laboratory test results with Emrelis are:

• decreased white blood cell counts
• increased blood sugar levels
• increased blood liver enzyme levels
• decreased blood phosphorus levels
• decreased blood sodium levels
• decreased red blood cell counts
• decreased blood calcium levels.

Emrelis may cause fertility problems in females and males, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

Serious side effects and warnings

Emrelis can cause the following serious side effects:

• Nerve problems in your hands or feet (peripheral neuropathy). Nerve problems are common during treatment with Emrelis and can also be severe. Tell your healthcare provider if you develop any new or worsening signs or symptoms of nerve problems, including: numbness tingling burning sensation pain or discomfort muscle weakness difficulty walking.
• Lung problems. Emrelis can cause lung problems that may be severe, life-threatening or that may lead to death. Tell your healthcare provider right away if you develop new or worsening lung symptoms, including: cough trouble breathing or shortness of breath fever wheezing.
• Eye problems. Your healthcare provider may send you to an eye care professional to check your eyes if you develop eye problems. Tell your healthcare provider right away if you develop any new or worsening eye problems or vision changes, including: blurred vision dry eyes sensitivity to light eye pain or swelling eye redness.
• Infusion-related reactions. Emrelis can cause infusion reactions that can be severe or life-threatening. Tell your healthcare provider right away if you develop any signs and symptoms of infusion reactions, including: itching or rash shortness of breath or wheezing flushing chest discomfort fever back pain chills headache nausea or vomiting feel like passing out.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Emrelis and may provide treatment for your side effects. Your healthcare provider may also need to change your dose, temporarily stop, or completely stop treatment with Emrelis if you have severe side effects.

These are not all the possible side effects of Emrelis. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Your healthcare provider will give you Emrelis into your vein through an intravenous (IV) line over 30 minutes.

• Emrelis is given 1 time every 2 weeks.
• Your healthcare provider will decide how many infusions of Emrelis you will receive.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking certain medicines with Emrelis may increase your risk of side effects.

Active ingredient: telisotuzumab vedotin-tllv

Inactive ingredients: histidine, polysorbate 80, sucrose. Hydrochloric acid is added to adjust the pH.

Emrelis is available as a lyophilized powder of telisotuzumab vedotin-tllv in a single-dose vial for reconstitution (20 mg or 100 mg).

Emrelis (telisotuzumab vedotin-tllv) is manufactured by AbbVie Inc., in North Chicago, IL.