AstraZeneca’s (AZ) Tagrisso (osimertinib) has been approved by the US Food and Drug Administration (FDA) to treat a new subset of lung cancer patients.
The epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor has been specifically authorised to treat unresectable, stage 3 non-small cell lung cancer (NSCLC) in adults whose disease expresses EGFR exon 19 or exon 21 mutations and has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy.
The approval was based on positive results from the late-stage LAURA trial, in which Tagrisso reduced the risk of disease progression or death by 84% compared to placebo.
Median progression-free survival was 39.1 months in patients receiving Tagrisso versus 5.6 months for placebo, and the safety and tolerability of AZ’s drug was consistent with its established profile.
More than 200,000 people are diagnosed with lung cancer in the US every year, and NSCLC accounts for up to 85% of cases.
Approximately 15% of NSCLC patients in the US have EGFR mutations and, as a result, are particularly sensitive to treatment with an EGFR-tyrosine kinase inhibitor that blocks the cell-signalling pathways driving tumour cell growth.
Tagrisso is already authorised for patients with EGFR mutations in the first-line metastatic setting as a monotherapy and in combination with chemotherapy, as well as an adjuvant treatment for early-stage disease.
Dave Fredrickson, executive vice president, oncology business unit at AZ, said the latest approval “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 NSCLC can now benefit,” he said.
The announcement comes just one month after the FDA approved AZ’s Imfinzi (durvalumab) regimen to treat resectable early-stage (stage 2A to 3B) NSCLC and no known EGFR mutations or anaplastic lymphoma kinase rearrangements.
The drug, which is now approved in the US to treat both resectable and unresectable NSCLC, was authorised for use alongside neoadjuvant chemotherapy before surgery and then as an adjuvant monotherapy after surgery.