The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a positive scientific opinion for Merck’s tepotinib for the treatment of advanced non-small cell lung cancer (NSCLC) with METex14 skipping alterations.
The positive opinion has been issued via the MHRA’s early access the medicine (EAMS) scheme, which aims to give patients access to medicines that do not yet have a marketing authorisation but where there ‘is a clear unmet medical need’.
The MHRA granted tepotinib opinion based on results from the Phase II VISION study which is evaluating the MET inhibitor as monotherapy in patients with advanced or metastatic NSCLC with METex14 skipping alterations.
In this study, tepotinib demonstrated an objective response rate of 46% following an independent review in the combined-biopsy group.
“We are delighted by the MHRA’s positive decision to provide early access to tepotinib for patients with advanced NSCLC harbouring METex14 skipping alterations in the United Kingdom, as there is a significant unmet need for new treatment options for these patients, who typically have a poor clinical prognosis. We believe this is a major advance in the treatment of these patients,” said Mike England, medical director, Merck UK & Ireland.
NSCLC is the most common form of lung cancer and accounts for 80-85% of all lung cancer diagnoses. Of those cases, approximately 3-4% occur with METex14 alterations and typically carry a poorer clinical prognosis compared with other types of NSCLC.