New Treatment Aumolertinib Approved for EGFR-Positive NSCLC

Key Highlight:

• Aumolertinib approved for metastatic NSCLC with EGFR mutations.
• Reduces disease progression or death risk by 54% in clinical trial.
• MHRA ensures safety, quality, and effectiveness of new treatment.

Aumolertinib (Aumseqa) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for adult patients with non-small cell lung cancer (NSCLC). Patients who have not yet received treatment for their cancer that has spread to other parts of their body (metastatic cancer) and who have tested positive for a mutation in the gene known as the epidermal growth factor receptor (EGFR) may utilize aumolertinib. Even if the metastatic cancer has previously received treatment, it may still be employed in some situations. This medication is given as tablets that are to be taken orally.

Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said:?“Patient safety is our top priority, and I’m pleased to confirm that aumolertinib has met the MHRA’s standards for safety, quality and effectiveness.

?“This approval offers a new treatments option for patients with advanced non-small cell lung cancer who have tested positive for EGFR mutations – a group for whom targeted therapies can be particularly important. ?“As with all products, we will keep aumolertinib’s safety under close review.” 

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By targeting EGFR, aumolertinib may help slow or even stop the growth of lung cancer. It might also aid in shrinking the tumor. When compared to gefitinib, an already-approved cancer medication, aumolertinib was found to reduce the risk of disease progression or death by 54% in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who had particular EGFR mutations in a Phase 3 clinical trial.