The U.S. Food and Drug Administration (FDA) has approved Tepmetko® (tepotinib) as a targeted treatment for adults with certain forms of non-small cell lung cancer (NSCLC) that has metastasized, or spread from where it started in the body. NSCLC is the most common type of lung cancer.1-3
Specifically, tepotinib is approved to treat metastatic NSCLC with MET exon 14 skipping alterations. This is estimated to be present in about 4 percent of NSCLC cases and is more common in people over age 70. The prognosis, or projected outcome, for this type of cancer is typically poor. This motivated the development of a targeted treatment. The MET exon 14 skipping alterations genetic abnormality can be detected with liquid or tissue sample biopsies.1,4
Tepotinib was granted accelerated approval by the FDA. Accelerated approval is sometimes granted to new drugs that are promising and could make a positive impact on the treatment of serious conditions. This helps drugs like tepotinib become available sooner.5
Continued approval of tepotinib may depend on more clinical trials confirming the drug’s safety and effectiveness. Merck KGaA, the drug company that makes tepotinib, is working to make tepotinib part of treatment plans for people with metastatic NSCLC with MET exon 14 skipping alterations.1,4
What are the ingredients in tepotinib?
The active ingredient in tepotinib is tepotinib hydrochloride hydrate.6
How does tepotinib work?
In people with NSCLC with MET exon 14 skipping alterations, the MET gene does not function correctly. Instead, it sends out instructions to cells that can cause tumor growth or worsen cancer in other ways. Tepotinib is a type of drug called a MET inhibitor. It is designed to target the cancer by reducing the impact from the MET gene by limiting the instructions the MET gene can send to cells.4
What are the possible side effects of tepotinib?
The most common side effects of tepotinib include:1,6
- Nausea and diarrhea
- Shortness of breath
- Swelling (edema)
- Pain in muscles and bones
Less common but serious possible side effects include:
- Lung inflammation
- Liver damage
These are not all the possible side effects of tepotinib. Talk to your doctor about what to expect or if you experience any changes that concern you during treatment with tepotinib.
Things to know about tepotinib
Tepotinib may interact with some other drugs. When tepotinib is taken with a certain type of drug called a CYP3A inducer, it may reduce the effects of tepotinib. CYP3A inducer drugs are varied and include certain other cancer drugs and some seizure drugs. If tepotinib is taken with other drugs called P-gp inhibitors and CYP3A inhibitors, it can potentially lead to dangerous levels of tepotinib in the body. Examples include certain heart medicines and some anti-infective drugs.6,7
Tepotinib can harm an unborn baby. Women who can become pregnant and men with partners who can become pregnant should use birth control (contraception) during treatment and for a period of time after the last dose of tepotinib. Talk to your doctor about the right birth control options and how long you need to use them. Women should also not breastfeed during treatment with tepotinib and for a period of time after the last dose. Talk to your doctor about the right breastfeeding options.6
Before beginning treatment for lung cancer, tell your doctor about all your health conditions, as well as any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.
For more information, read the full prescribing information of tepotinib.