FDA grants fast review for AstraZeneca's Tagrisso in early-stage lung cancer


The FDA has granted a fast review for AstraZeneca’s Tagrisso oncology drug in certain patients with early-stage lung cancer.

Results from the phase 3 ADAURA trial were the talk of this year’s American Society of Clinical Oncology (ASCO) conference in summer and the regulator has granted a Priority Review for a label extension based on the results.

The FDA reserves these faster reviews, taking six months at the most instead of the standard ten-month timeframe, for medicines that demonstrate superior efficacy or safety for serious diseases.

ADAURA tested Tagrisso (osimertinib) in patients with early-stage (1B, II and III) epidermal growth factor receptor-mutated (EGFR) non-small cell lung cancer (NSCLC) after complete tumour removal.

Up to 30% of all patients diagnosed early with NSCLC in this patient group may be diagnosed early enough to have curative surgery, but disease recurrence is common and more than three quarters of patients diagnosed in Stage IIIA experience recurrence within five years.

ADAURA was halted early this year after Tagrisso showed “overwhelming efficacy” in this patient group.

In the trial Tagrisso reduced the risk of disease recurrence or death by 83% compared to placebo in patients with tumours that had spread locally but not to other parts of the body (stage II-IIIa), and who had surgery with the aim of completely removing the tumour and curing their cancer.

The drug also reduced disease-free survival by 79% in the overall trial population (stage 1b to IIIa), and after two years 89% of patients remained alive, compared to 53% of the placebo group.

It’s the first time that a targeted drug has shown an improvement in this group of patients in a large scale trial.

Approval will be another string in the bow for Tagrisso, which is already a blockbuster bringing in revenues of more than $1 billion per quarter for the UK pharma.

Tagrisso is a third-generation irreversible EGFR-tyrosine kinase inhibitor that was originally intended to treat patients with EGFR-mutated NSCLC after an older drug from that class has been rendered useless by a T790M mutation, which usually occurs after around 18 months of treatment.

But since this first FDA approval in 2015 it has also been licensed in first-line treatment in EGFR-mutated lung cancer, after outperforming AZ’s older EGFR drug Iressa (gefitinib) and Roche’s rival Tarceva (erlotinib) in the phase 3 FLAURA trial.