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European Commission Approves TEPMETKO® (tepotinib) for Patients with Advanced NSCLC with METex14 Skipping Alterations


Merck, a leading science and technology company, today announced that the European Commission (EC) has approved once-daily oral TEPMETKO® (tepotinib) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

“The approval of TEPMETKO provides a much-needed targeted treatment option for patients with advanced non-small cell lung cancer with METex14 skipping alterations,” said Professor Egbert Smit, a VISION study investigator at the Netherlands Cancer Institute. “TEPMETKO has demonstrated durable and consistent response rates and has the potential to significantly help patients with this challenging cancer.”

The approval is based on results from the pivotal Phase II VISION study evaluating TEPMETKO as monotherapy in patients with advanced NSCLC with METex14 skipping alterations. Data from the primary analysis of the VISION study were previously published online in The New England Journal of Medicine.

“The approval of TEPMETKO in Europe helps to address the need for targeted treatment options for people with lung cancer who have received prior treatment and whose tumors harbor METex14 skipping alterations,” said Dr. Anne-Marie Baird, President of Lung Cancer Europe. “It is vital that biomarker testing is made consistently available and utilized across Europe to ensure people with advanced lung cancer receive an accurate diagnosis and optimal treatment.”

In Europe, lung cancer is estimated to be the second most common cancer and the leading cause of cancer-related mortality, responsible for 388,000 deaths in 2018.2 Alterations of the MET signaling pathway, including METex14 skipping alterations, are found in 3% to 4% of NSCLC cases and are associated with advanced disease and poor prognosis.

“With the European Commission’s approval of TEPMETKO, we are now able to bring this important medicine to more patients with this hard-to-treat and aggressive form of lung cancer,” said Andrew Paterson, Chief Marketing Officer for the Healthcare business sector of Merck. “As pioneers in the targeting of the MET signaling pathway, we will now be working on ways to bring this medicine to patients in Europe who may benefit.”
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