The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended AstraZeneca’s (AZ) Tagrisso for approval in the EU for the treatment of early-stage lung cancer patients.
Specifically, the CHMP has recommended a marketing authorisation for Tagrisso (osimertinib) for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection.
The positive opinion is based on results from the Phase III ADAURA trial, in which Tagrisso demonstrated a statistically significant improvement in disease-free survival in the primary analysis population of patients with early-stage EGFRm NSCLC.
In April 2020, the Independent Data Monitoring Committee (IDMC) recommended unblinding this trial two years early based on ‘overwhelming efficacy’. The trial is set to continue with the aim of assessing overall survival.
“With no targeted treatment options currently available for early-stage lung cancer patients after surgery in the EU, recurrence rates remain unacceptably high,” said Dave Fredrickson, executive vice president, oncology business unit at AZ.
“This positive recommendation is a vital step towards introducing a targeted treatment option for these patients for the first time,” he added.
In the US and China, Tagrisso is approved to treat early-stage lung cancer, and is also approved for the first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC in the EU, the US, Japan and China.
Tagrisso is a third-generation tyrosine kinase inhibitor targeted against EGFR – it is currently being tested in Phase III trials in the stage III locally unresectable setting, in the neoadjuvant resectable setting and in combination with chemotherapy.