The UK Medicines and Healthcare products Regulatory Agency (MHRA) has conditonally authorised Merck’s MET inhibitor Tepmetko (tepotinib) for the treatment of certain non-small cell lung cancer (NSCLC) patients.
The conditional marketing authorisation opens access to Tepmetko treatment for adult patients with advanced NSCLC harbouring mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping alterations.
The MHRA decision is based on results from the Phase II VISION study, evaluating Tepmetko monotherapy in patients with advanced or metastatic NSCLC with METex14 skipping alterations.
The efficacy of the therapy was evaluated among 146 patients, with the study demonstrating an objective response rate (ORR) by independent review of 45.2% in the combined-biopsy group.
“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,” said Paula Chadwick, chief executive, Roy Castle Lung Cancer Foundation.
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,” she added.
The authorisation was conducted through Project ORBIS – a pathway coordinated by the US Food and Drug Administration (FDA).
The programme is designed to review and approve promising cancer treatments concurrently with regulatory authorities in six countries, including the UK’s MHRA.
It aims to speed-up patient access to innovative cancer treatments with potential benefits over existing therapies ‘across the globe’.
As such, further evidence on Tepmetko is awaited under the conditional marketing authorisation scheme.