The approval followed a Priority Review by the FDA and was based on results from the FLAURA2 phase 3 trial, which were published in The New England Journal of Medicine. The drug, combined with chemotherapy, reduced the risk of disease progression or death by 38% compared to Tagrisso as a monotherapy, the current global standard of care.

Median progression-free survival (PFS) assessed by investigators was 25.5 months for patients treated with Tagrisso plus chemotherapy, compared to 16.7 months for the drug as a monotherapy.

Dave Fredrickson, executive vice president of the Oncology Business Unit at AstraZeneca, commented: “This important new treatment option can delay disease progression by nearly nine additional months, establishing a new benchmark with the longest reported progression-free survival benefit in the firstline advanced setting. This approval reinforces Tagrisso as the backbone of EGFR-mutated lung cancer treatment either as monotherapy or in combination with chemotherapy. This news is especially important for those with a poorer prognosis, including patients whose cancer has spread to the brain and those with L858R mutations.”

Laurie Ambrose, president and chief executive officer of GO2 for Lung Cancer, added: “We are so excited to see this continued progress advancing more personalised treatment options for our community. The more we can target the right treatments for the right people at the right time, the better outcomes will be for our community – a goal we all collectively share.”

Pasi A Jänne MD PhD, medical oncologist at Dana-Farber Cancer Institute, US, and principal investigator for the trial, stated: “This approval based on the unprecedented data from FLAURA2 brings a critical new treatment option to patients with advanced EGFR-mutated non-small cell lung cancer. Now, with the choice of two highly effective osimertinib-based options, physicians can better tailor treatment to an individual’s needs and help ensure the best possible outcome for each patient.”