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FDA Approves Tagrisso Plus Chemotherapy for Advanced EGFR-Mutated Lung Cancer

NEW YORK – AstraZeneca on Monday said the US Food and Drug Administration approved Tagrisso (osimertinib) as a treatment for patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer.

AstraZeneca also on Monday reported positive results from the LAURA Phase III trial of Tagrisso compared to placebo as a treatment for stage III EGFR-mutated NSCLC following chemoradiotherapy. Although the data were not yet mature, the company said patients treated with Tagrisso showed a favorable trend toward improved overall survival with safety and tolerability consistent with previous studies of the drug. AstraZeneca plans to share the data with global regulatory authorities.

The FDA's decision was based on results from the FLAURA2 Phase III trial in which treatment with Tagrisso and chemotherapy reduced the risk of disease progression or death by 38 percent compared to Tagrisso alone. Among patients treated with Tagrisso-chemotherapy, median progression-free survival was 25.5 months compared to 16.7 months for Tagrisso monotherapy.

In an exploratory analysis of patients in FLAURA2 with brain metastases at baseline, Tagrisso-chemotherapy reduced the risk of central nervous system disease progression or death by 42 percent compared to Tagrisso monotherapy. After two years of follow-up, 74 percent of patients in that group were still alive and had not experienced CNS disease progression compared with 54 percent of those treated with Tagrisso alone.

Overall survival results for the trial were still immature at the time of the second interim analysis.

"This approval reinforces Tagrisso as the backbone of EGFR-mutated lung cancer treatment either as monotherapy or in combination with chemotherapy," Dave Fredrickson, executive VP of AstraZeneca's oncology business unit, said in a statement. "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."

Tagrisso has previously been approved as a first-line treatment for locally advanced or metastatic EGFR-mutated NSCLC, including T790M mutation-positive NSCLC, and as an adjuvant treatment for early-stage EGFR-mutated NSCLC. The National Comprehensive Cancer Network in December added Tagrisso with chemotherapy to its Clinical Practice Guidelines in Oncology as a recommended regimen for patients with NSCLC whose tumors harbor EGFR exon 19 deletions or exon 21 L858R mutations based on the FLAURA2 results.

The FDA reviewed AstraZeneca's submission under Project Orbis, which supports concurrent submission and review of oncology medicines between participating international partners. Australia, Canada, and Switzerland are also currently reviewing Tagrisso plus chemotherapy as a treatment for EGFR-mutated NSCLC.