The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a Marketing Authorisation for a new oral treatment for advanced non-small cell lung cancer (NSCLC).
The conditional Marketing Authorisation (CMA) in Great Britain for tepotinib (Tepmetko) is for the treatment of adult patients with NSCLC harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations.
This authorisation is based on results from the Phase II VISION study evaluating tepotinib as monotherapy in patient with advanced or metastatic NSCLC with METex14 skipping alterations, prospectively assessed by liquid biopsy or tissue biopsy. Efficacy was evaluated in 146 patients and the study demonstrated an objective response rate, the primary outcome measure, by independent review of 45.2% (95% confidence interval [CI], 37.0 to 53.6) in the combined-biopsy group.
Professor Sanjay Popat, Consultant Thoracic Medical Oncologist, The Royal Marsden NHS Foundation Trust, added: “This is the first MHRA authorised MET inhibitor to be made available to eligible patients, and as such would have a significant impact on their current clinical outcomes. This authorisation is an important advancement for patients with METexon14 skipping aberrations and represents a significant step forward in the development of new targeted therapies in advanced NSCLC.”
Vital we have as many treatment options available to patients
NSCLC is the most common type of lung cancer and accounts for approximately 80-85% of all lung cancer diagnoses in the UK. METex14 alterations occur in approximately 3-4% of NSCLC cases and generally exhibit a poorer clinical prognosis compared with other types of NSCLC.
Paula Chadwick, Chief Executive, Roy Castle Lung Cancer Foundation, said: “We welcome the decision by the MHRA to authorise the targeted therapy, tepotinib. Lung cancer can be an aggressive, hard-to-treat cancer so it is vital we have as many treatment options available to patients so they can live well with this disease for as long as possible. This decision takes us a step closer to having another treatment for people in this country who are living with non-small cell lung cancer."