AstraZeneca (AZ) has received marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for its Imfinzi (durvalumab) regimen in a subset of adults with resectable non-small cell lung cancer (NSCLC).
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.
Patients eligible for the regimen will have resectable NSCLC and no known epidermal growth factor receptor mutations, ALK rearrangements or aberrations.
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.
Lung cancer accounts for 21% of all cancer deaths in the UK and NSCLC accounts for up to 85% of all lung cancer diagnoses.
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”.
Hardland added that the company is now “committed to working with the National Institute for Health and Care Excellence and NHS England to ensure rapid access for patients”.
Sharing a similar sentiment, Dr John Conibear, clinical director of thoracic oncology at Barts Cancer 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.”
The approval comes just over one week after Imfinzi and AZ’s PARP inhibitor Lynparza (olaparib) were recommended by the European Medicines Agency’s human medicines committee to treat certain endometrial cancer patients.
The Committee for Medicinal Products for Human Use recommended Imfinzi plus chemotherapy as a first-line treatment, followed by Lynparza and Imfinzi, for use in patients with mismatch repair proficient primary advanced or recurrent endometrial cancer. Imfinzi plus chemotherapy, followed by Imfinzi alone, was also recommended to treat those with mismatch repair deficient disease