AZ’s Tagrisso gets FDA nod in first-line EGFR-mutated lung cancer

pharmafile | April 19, 2018 | News story | Sales and Marketing AstraZeneca, Cancer, EGFR-TKIs, NSCLC, Tagrisso, lung cancer, pharma 

AstraZeneca has announced that its epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) has received approval from the FDA for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumours have EGFR mutations, specifically exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

The decision was made by the US regulator off the back of Phase 3 data which showed that Tagrisso outperformed other current first-line EGFR-TKIs erlotinib and gefitinib in previously-untreated patients with locally-advanced or metastatic EGFR-mutated NSCLC. AZ’s drug met its primary endpoint of progression-free survival (PFS), consistent across all pre-specified patient subgroups.

In the trial, Tagrisso demonstrated a median PFS of 18.9 months compared to 10.2 months with current EGFR-TKIs, while median duration of response was 17.6 months compared to just 9.6 months. Objective response rate of 77% for Tagrisso stood at 77% compared to 69%, with a partial response rate of 75% to 68%. Complete response rate showed a negligible difference at 2% versus 1%. According to the manufacturer, overall survival data were “not mature” at the time of final PFS analysis.

Previously in the US, Tagrisso was approved for the second-line treatment of metastatic EGGFR-mutated NSCLC in patients whose disease has progressed despite receiving a first-line EGFR-TKI therapy and have developed the secondary T790M mutation. The drug is currently awaiting a regulatory decision in the EU and Japan, due to be made in the second half of the year.

“Today’s FDA approval of Tagrisso in the first-line setting is an exciting milestone for patients and our company. Tagrisso delivered unprecedented median progression-free survival data across all pre-specified patient subgroups, including patients with or without CNS metastases, and could prolong the lives of more patients without their tumours growing or spreading,” remarked Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca.

Dr Suresh S Ramalingam, Principal Investigator of the FLAURA trial, from Winship Cancer Institute of Emory University in Atlanta, added: “The approval of osimertinib in the first-line setting represents a major advance in the treatment of patients with EGFR mutations and a significant change in the treatment paradigm. Osimertinib provides robust improvements in progression-free survival with no unexpected safety signals compared to the previous generation of EGFR inhibitors.”

Matt Fellows

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