AstraZeneca has obtained US approval for Tagrisso in adult patients with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC).
The threapeutic, otherwise called osimertinib, is suitable for patients whose disease hasn't progressed while receiving sequential rounds of chemotherapy.
It is only to be used by patients with exon 19 deletions to exon 21 mutations.
This approval comes off the back of a Priority Review by the US Food and Drug Administration, which detailed the results of the LAURA Phase III trial.
During the LAURA trial, Tagrisso reduced the risk of disease progression or death by 84% compared to placebo, while also increasing median progression-free survival by 33.5 months.
The trial is currently assessing the overall survival of patients as a secondary endpoint.
The safety and tolerability of Tagrisso was also found to be consistent in the Phase III LAURA trial.
Suresh Ramalingam, Executive Director of Winship Cancer Institute of Emory University, Atlanta, US, and principal investigator in the trial, said: “This approval represents a major breakthrough for patients with Stage III, EGFR-mutated lung cancer who will now have the opportunity to benefit from osimertinib."
"Patients treated with osimertinib lived without disease progression by more than three years in the LAURA trial, and this impressive benefit underscores the importance of diagnosing and testing lung cancer patients as early as possible.”
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “The approval of Tagrisso for patients with Stage III, unresectable EGFR-mutated non-small cell lung cancer addresses a critical need for patients with these mutations who have never had the option of targeted therapy before."
"The results of the LAURA trial show the powerful impact Tagrisso can make as backbone therapy in this disease, and with this approval, patients across all stages of EGFR-mutated non-small cell lung cancer can now benefit.”
Tagrisso is currently under review in other countries globally for EGFR-mutated NSCLC.