Osimertinib Receives Approval From FDA for EGFR-Mutated Locally Advanced or Metastatic NSCLC

Osimertinib Receives Approval From FDA for EGFR-Mutated Locally Advanced or Metastatic NSCLC

Osimertinib (Tagrisso) has been approved by the FDA for use with platinum-based chemotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.

This approval was based on findings from the FLAURA 2 (NCT04035486) trial, which assessed 557 patients with EGFR exon 19 deletion or exon 21 L858R mutation-positive locally advanced or metastatic NSCLC and had not been previously treated with systemic therapy for advanced disease, according to the alert from the FDA. In this open-label, randomized trial, patients were randomized 1:1 to receive either osimertinib with platinum-based chemotherapy or osimertinib monotherapy.

The major efficacy outcome measure of the FLAURA 2 trial was progression-free survival (PFS), which was assessed by the investigator. The key secondary outcome measure was overall survival (OS).

Patients treated with osimertinib plus platinum-based chemotherapy had a statistically significant improvement in PFS vs those treated with osimertinib alone (HR = 0.62; 95% CI, 0.49-0.79; two-sided P value < .0001). The median PFS in the osimertinib plus chemo group was 25.5 months (95% CI, 24.7-not estimable) compared with 16.7 months (95% CI, 14.1-21.3) in the osimertinib monotherapy group.

At the current analysis of this trial, OS results were immature, with 45% of prespecified deaths for the final analysis reported, although there was no trend towards a detriment, according to the alert.

The most common adverse reactions, occurring in at least 20% of patients, in patients treated with osimertinib plus platinum-based chemotherapy included thrombocytopenia, leukopenia, neutropenia, rash, lymphopenia, stomatitis, diarrhea, dry skin, nail toxicity, and increased blood creatinine levels.

The FDA recommends an 80-mg dose of osimertinib orally once per day either with or without food, and for the drug to be given until disease progression or unacceptable toxicity.

Reference

FDA approves osimertinib with chemotherapy for EGFR-mutated non-small cell lung cancer. FDA. February 16, 2024. Accessed February 16, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-chemotherapy-egfr-mutated-non-small-cell-lung-cancer