FDA approves Tagrisso plus chemotherapy for EGFR-mutated non-small cell lung cancer
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The FDA approved osimertinib plus platinum-based chemotherapy for certain adults with locally advanced or metastatic non-small cell lung cancer.
The indication applies to individuals with tumors that harbor EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
Osimertinib (Tagrisso, AstraZeneca) is a third-generation tyrosine kinase inhibitor. The agent previously received FDA approval for three other EGFR-mutant NSCLC indications.
The FDA approved the osimertinib-led regimen based on results from the phase 3 FLAURA 2 study. The open-label trial evaluated the saftey and efficacy of osimertininb plus chemotherapy in 557 adults with EGFR exon 19 deletion or exon 21 L858R mutation-positive locally advanced or metastatic NSCLC who received no previous systemic therapy for advanced disease.
Study investigators randomly assigned participants in a 1:1 ratio to receive osimertinib with platinum-based chemotherapy or osimertinib monotherapy.
Investigator-assessed PFS served as the study’s major efficacy outcome measurement, with OS as a key secondary outcome.
Study results showed osimertinib plus platinum-based chemotherapy conferred a significant improvement in PFS compared with osimertinib monotherapy (HR = 0.62; 95% CI, 0.49-0.79). Researchers reported median PFS of 25.5 months (95% CI, 24.7 to not estimable) for osimertininb plus chemotherapy compared with 16.7 months (95% CI, 14.1-21.3) for osimertinib alone.
The most common adverse reactions occurring in more than 20% of study participants receiving osimertinib plus platinum-based chemotherapy included leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash, diarrhea, stomatitis, nail toxicity, dry skin, and increased blood creatinine levels.
“This approval based on the unprecedented data from FLAURA2 brings a critical new treatment option to patients with advanced EGFR-mutated non-small cell lung cancer,” Pasi A. Jänne, MD, PhD, medical oncologist at Dana-Farber Cancer Institute and the trial’s principal investigator, said in an AstraZeneca-issued press release. “Now, with the choice of two highly effective osimertinib-based options, physicians can better tailor treatment to an individual’s needs and help ensure the best possible outcome for each patient.”
References:
- FDA approves osimertinib with chemotherapy for EGFR-mutated non-small cell lung cancer (press release). Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-chemotherapy-egfr-mutated-non-small-cell-lung-cancer. Published Feb. 16, 2024. Accessed Feb. 19, 2024.
- Tagrisso with the addition of chemotherapy approved in the US for patients with EGFR-mutated advanced lung cancer (press release). Available at: https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-plus-chemo-approved-in-us-for-lung-cancer.html. Published Feb. 19., 2024. Accessed Feb. 19, 2024.
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