AstraZeneca's Tagrisso approved by FDA for advanced NSCLC

The FDA on Friday granted accelerated approval to AstraZeneca's Tagrisso (osimertinib) for the treatment of patients with advanced non-small-cell lung cancer (NSCLC) whose tumours carry the T790M mutation in epidermal growth factor receptor (EGFR) and whose disease worsened after treatment with other EGFR-blocking therapy. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, explained that the approval "is based on substantial evidence from clinical trials that shows Tagrisso had a significant effect on reducing tumour size in over half of patients who were treated."

The FDA noted that the approval was backed by safety and efficacy data from two single-arm studies involving a total of 411 patients with advanced EGFR T790M mutation-positive NSCLC whose disease progressed after treatment with an EGFR inhibitor. In the studies, objective response rates of 57 percent and 61 percent, respectively, were observed for Tagrisso-treated patients.

AstraZeneca previously highlighted the drug, also known as AZD9291, as a key component of its pipeline, and estimated that the therapy could eventually amass $3 billion in annual revenue.

The FDA on Friday also cleared Roche's cobas EGFR Mutation Test v2, which the agency said is the first companion diagnostic test to detect the specific EGFR mutation targeted by Tagrisso. The regulator noted that the diagnostic test adds the T790M mutation to the mutations detected by the first version of the test.

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