The anti-PDL1 antibody is now approved in Great Britain for use alongside platinum-based chemotherapy as a neoadjuvant treatment before surgery and then as an adjuvant monotherapy after surgery.
The MHRA’s decision, which means that Imfinzi is now approved in Great Britain to treat both resectable and unresectable NSCLC, was supported by positive results from the late-stage AEGEAN trial.
Patients treated with the Imfinzi regimen achieved a 32% reduction in the risk of recurrence, progression or death compared to neoadjuvant chemotherapy alone.
The combination also demonstrated a pathologic complete response rate of 17.2% versus 4.3% for patients receiving neoadjuvant chemotherapy only.
David Harland, head of oncology medical affairs, AZ UK, said the latest approval “marks a major advancement and opens a new chapter in the treatment of resectable NSCLC”.
Sharing a similar sentiment, Dr John Conibear, clinical director of thoracic oncology at Barts Cancer CentreCancer Centre, said: “This decision by the MHRA recognises an important clinical improvement in outcomes for patients with resectable NSCLC, where new options are urgently needed for long-term survival.”
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