A new treatment for a particularly aggressive type of lung cancer has received fast-track approval from the U.S. Food and Drug Administration. Emrelis, also known by its scientific name telisotuzumab vedotin, is now available for adults with advanced non-squamous non-small-cell lung cancer (NSCLC) whose tumors overproduce a protein called c-Met and who have already undergone previous therapies.
This approval marks a significant advancement in the treatment of NSCLC, the most common form of lung cancer. Accounting for about 85% of all lung cancer cases, NSCLC often becomes more difficult to treat when patients no longer respond to standard therapies. Among these patients, approximately 25% have tumors that overproduce the c-Met protein, which is associated with more aggressive disease and poorer outcomes.
Emrelis is part of a new class of drugs called antibody-drug conjugates (ADCs). These medicines are designed to selectively target and attack cancer cells while sparing healthy ones. Emrelis combines a monoclonal antibody that specifically seeks out c-Met proteins with a potent chemotherapy drug known as monomethyl auristatin E (MMAE). When Emrelis binds to cancer cells that overexpress c-Met, it delivers the chemotherapy drug directly into those cells, disrupting cell division and preventing the tumor from growing further.
The drug is administered via intravenous infusion every two weeks, and patients will continue receiving it for as long as it remains effective and the side effects are manageable.
Approval was based on results from a clinical trial involving 84 patients with advanced NSCLC that produced too much c-Met and who had already been treated with other therapies. The trial showed a response rate of 35%, with effects lasting an average of 7.2 months. Continued approval will depend on additional data confirming the treatment’s benefits in future clinical trials, including an ongoing global study evaluating the use of Emrelis on its own.
To help determine which patients may benefit from this treatment, the FDA has also approved a lab test developed to detect elevated c-Met protein levels in tumor samples. This allows for a more personalized approach to lung cancer treatment, targeting therapies based on specific biomarkers.
Despite its promise, Emrelis does come with side effects. The most common include peripheral neuropathy (nerve damage in the hands and feet), fatigue, reduced appetite, swelling in limbs, infusion-related reactions, and abnormal blood test results such as elevated liver enzymes or low levels of hemoglobin, sodium, calcium, phosphorus, and white blood cells.
Before starting Emrelis, patients are advised to discuss their full medical history with their healthcare provider, especially if they have pre-existing nerve issues, liver disease, breathing difficulties unrelated to cancer, or eye conditions. It’s important to inform the doctor about any medications, supplements, or vitamins currently being taken, as some may interact with the drug and heighten the risk of side effects.
There are also specific precautions for people of reproductive age. Emrelis can harm unborn babies, so women who are pregnant or planning pregnancy should inform their healthcare provider. Women must undergo a pregnancy test before treatment and use effective birth control during treatment and for two months afterward. Men whose partners may become pregnant should use birth control during treatment and for four months after the final dose. Breastfeeding is also not recommended during treatment and for at least one month after the final infusion.
Patients are urged to promptly report symptoms such as numbness, muscle weakness, difficulty walking, breathing problems, chest discomfort, fever, chills, rash, or visual changes, which may signal serious side effects requiring immediate medical attention.
Emrelis offers a new hope to patients with c-Met overexpressing NSCLC, filling a critical gap in lung cancer treatment and opening the door to more individualized, targeted care.
