Advertisment

FDA Approves Tepotinib for Treatment of Metastatic Non-Small Cell Lung Cancer (NSCLC)

author-image
Medriva Correspondents
New Update
NULL

FDA Approves Tepotinib for Treatment of Metastatic Non-Small Cell Lung Cancer (NSCLC)

Advertisment

The U.S. Food and Drug Administration (FDA) has approved tepotinib, marketed under the name Tepmetko by EMD Serono, Inc., for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) who harbor mesenchymal-epithelial transition (MET) exon 14 skipping alterations. This landmark approval was based on the findings of the VISION trial, which observed the drug's efficacy in 313 patients suffering from metastatic NSCLC harboring MET exon skipping alterations.

Advertisment

The VISION Trial

The VISION trial was a phase 2 study that evaluated the efficacy of tepotinib in patients with NSCLC who have MET exon 14 skipping alterations. The primary efficacy measures in the trial were the overall response rate (ORR) and duration of response (DOR). The trial revealed an ORR of 57% for treatment-naive patients and 45% for patients who had received previous treatments. Furthermore, 40% of the responders showed a DOR that lasted a year (12 months) or more.

Recommended Dosage and Side Effects

Advertisment

The FDA recommends a dose of 450 mg of tepotinib to be taken orally once daily with food. However, like all treatments, tepotinib can cause side effects. The most common adverse reactions observed in the VISION trial included edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash. These adverse effects were experienced by 20% or more of the patients in the trial.

Breakthrough and Orphan Drug Designations

The FDA has granted breakthrough designation and orphan drug designation to tepotinib. The breakthrough designation is given to drugs that potentially offer significant benefits over existing treatments for serious or life-threatening diseases. The orphan drug designation, on the other hand, is given to drugs that treat rare diseases affecting fewer than 200,000 people in the U.S. Healthcare professionals are encouraged to report any adverse events related to the use of tepotinib to the FDA's MedWatch Reporting System.

Advertisment

Evolution of Lung Cancer Treatment

The approval of tepotinib is part of the broader evolution in the classification and treatment of lung cancer. Researchers are continually identifying and targeting new molecular alterations in non-small cell lung cancer. This has led to the development of a variety of druggable molecular targets in lung adenocarcinoma, including EGFR, ALK, BRAF, ROS1, KRAS, HER2, MET, RET, and NTRK. Trials are also ongoing for other targets such as PI3K and FGFR.

Combating MET Resistance

Another exciting development in lung cancer treatment is the use of combinations of parent and MET tyrosine kinase inhibitors (TKIs) to treat acquired MET resistance in patients with metastatic oncogene-driven NSCLC. Studies have found that combining MET TKIs with parent TKIs can be efficacious, with no significant differences in radiographic response and adverse events based on the underlying MET TKI used.

The approval of tepotinib by the FDA is a significant step forward in the treatment of NSCLC with MET exon 14 skipping alterations. It offers hope for patients seeking effective treatments and underscores the importance of continuous research and innovation in the fight against lung cancer.

Advertisment
Chat with Dr. Medriva !