New targeted lung cancer treatment coming to UK under MHRA scheme

pharmafile | July 15, 2021 | News story | |  MHRA, NSCLC, UK, brexit 

The MHRA has issued an Early Access to Medicines Scheme (EAMS) positive scientific opinion for tepotinib, for the treatment of adult patients with advanced Non-Small Cell Lung Cancer (NSCLC).

Tepotinib is a monotherapy developed by Merck, and the positive opinion was issued for patients with NSCLC that are harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations.

The MHRA opinion was issued based on results from the Phase II VISION study evaluating tepotinib as monotherapy in patients with advanced or metastatic NSCLC with METex14 skipping alterations, prospectively assessed by liquid biopsy or tissue biopsy. The VISION study demonstrated an objective response rate by independent review of 46% in the combined-biopsy group, with data from the primary analysis being published on NEJM in May 2020.

The EAMS aims to provide earlier availability of promising new unlicensed medicines to UK patients with high unmet clinical need. A positive scientific opinion is issued by the MHRA based on the positive benefit risk balance (quality, safety and efficacy assessment) and the ability of the company to supply a medicine according to a consistent quality standard.

An assessment of the quality, safety, and efficacy of the medicine is conducted by the MHRA’s assessment teams, including pharmacists, toxicologists, statisticians, pharmacokinetic and medical assessors. EAMS medicines are unlicensed medicines.

Tepotinib is a selective type 1b MET inhibitor which has shown clinical activity in MET driven tumours. It became the first oral MET inhibitor indicated for the treatment of advanced NSCLC harbouring MET gene alterations to receive a regulatory approval globally, with its approval in Japan in March 2020 through the SAKIGAKE programme. The FDA has also recently approved tepotinib under Priority Review ahead of its Prescription Drug User Fee Act (PDUFA).

Dr Mike England, Medical Director of Merck UK & Ireland, said: “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.”

Lung cancer is the third most common cancer in the UK, accounting for 13% of all new cancer cases in 2017, and was the leading cause of cancer related death in the UK in 2018. NSCLC is the most common type of lung cancer and accounts for approximately 80-85% of all lung cancer diagnoses. METex14 alterations occur in approximately 3-4% of NSCLC cases and generally exhibit a poorer clinical prognosis compared with other types of NSCLC.

Kat Jenkins

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