FDA Approves Osimertinib/Chemo in EGFR-Mutated NSCLC

The FDA has granted approval to osimertinib (Tagrisso) in combination with platinum-based chemotherapy as a treatment for patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 L858R mutations, according to a press release from the agency.¹

The regulatory agency approved osimertinib at a recommended dose of 80 mg orally twice a day with or without food until acceptable toxicity or progressive disease.

Supporting data for the approval of osimertinib in this indication came from the phase 3 FLAURA 2 trial (NCT04035486). Data highlighted a median progression-free survival (PFS) of 25.5 months (95% CI, 24.7-not estimable [NE) with osimertinib plus chemotherapy compared with 16.7 months (95% CI, 14.1-21.3) in those who received osimertinib monotherapy (HR, 0.62; 95% CI, 0.49-0.79; P <.0001).

Currently, overall survival data are still immature, but 45% of prespecified deaths were reported, and there was not a detriment observed.

In the open-label FLAURA 2 trial, 557 patients with EGFR-mutated advanced or metastatic NSCLC were randomly assigned 1:1 to receive osimertinib alone or in combination with platinum-containing chemotherapy.

The trial’s primary efficacy end point was PFS per investigator assessment. OS was a key secondary end point.

The most common adverse effects observed in the osimertinib/chemotherapy arm included leukopenia, thrombocytopenia, neutropenia, lymphopenia, and rash.

The FDA previously granted priority review to a supplemental biologics license application for osimertinib as a treatment for those with advanced or metastatic NSCLC harboring EGFR mutations in October 2023.²

References

1. FDA approves osimertinib with chemotherapy for EGFR-mutated non-small cell lung cancer. News release. FDA. February 16, 2024. Accessed February 16, 2024. https://bit.ly/49AeXjy
2. Tagrisso plus chemotherapy granted priority review in the US for patients with EGFR-mutated advanced lung cancer. News release. AstraZeneca. October 16, 2023. Accessed February 16, 2024. https://bit.ly/3ZUDUm9