The Medicines and Healthcare products Regulatory Agency (MHRA) has approved SFL Pharmaceuticals Deutschland’s Aumseqa (aumolertinib) to treat a subset of non-small cell lung cancer (NSCLC) patients.
The oral drug has been authorised for use in adults with untreated metastatic NSCLC who have tested positive for a mutation in the epidermal growth factor receptor (EGFR) gene, the MHRA said. The regulator added that, in certain cases, the drug may be used even if the metastatic cancer has been previously treated.
Approximately 43,000 people are diagnosed with lung cancer every year in the UK, with NSCLC accounting for up to 85% of all cases of the disease.
EGFR is involved in the growth and division of healthy cells. However, a mutation in the gene coding for EGFR can lead to the protein being significantly over-expressed, causing cells to grow out of control, which can lead to cancer.
Given in tablet form, Aumseqa is designed to block EGFR, which may help to slow or stop the lung cancer from growing, as well reduce tumour size.
Julian Beach, MHRA interim executive director of healthcare quality and access, said: “This approval offers a new treatment option for patients with advanced NSCLC who have tested positive for EGFR mutations – a group for whom targeted therapies can be particularly important.”
The MHRA’s decision was supported by phase 3 clinical trial results showing that Aumseqa reduced the risk of disease progression or death by 54% compared to gefitinib, an approved cancer drug, in patients with advanced or metastatic NSCLC who had specific EGFR mutations.
“Patient safety is our top priority, and I’m pleased to confirm that [Aumseqa] has met the MHRA’s standards for safety, quality and effectiveness,” Beach said.
The authorisation comes three months after the MHRA approved Johnson & Johnson’s Lazcluze (lazertinib), which is also designed to block EGFR, alongside the drugmaker’s approved cancer drug Rybrevant (amivantamab) to treat adults with NSCLC that has spread to other parts of the body and has undergone specific changes EGFR gene.