FDA Approves Post-Chemoradiation Osimertinib for Advanced NSCLC
The FDA approved osimertinib for locally advanced, unresectable stage III EGFR-mutated non-small cell lung cancer.
The FDA approved osimertinib (Tagrisso) for the treatment of adults with locally advanced, unresectable stage III non-small cell lung cancer (NSCLC) that did not progress during or after concurrent or sequential platinum-based chemoradiation therapy. The disease must also have EGFR exon 19 deletions or exon 21 L858R mutations, according to the agency.1
The approval is based on findings from the double-blind LAURA trial (NCT03521154).2 Patients were randomized 2:1 to receive either 80 mg of osimertinib daily or a placebo until disease progression or unacceptable toxicity.
Progression-free survival (PFS) assessed by blind independent central review served as the primary end points; the secondary end points was overall survival (OS).
Data from LAURA showed an improvement in PFS in the osimertinib group compared to the placebo group, reducing the risk for progression by 84% (HR, 0.16; 95% CI, 0.10-0.24; P < .001). Median PFS was 39.1 months (95% CI, 31.5-not estimable [NE]) and 5.6 months (95% CI, 3.7-7.4) in the osimertinib and placebo arms, respectively.
READ MORE: Osimertinib May Change Standard of Care for Stage III EGFR+ NSCLC After Definitive Chemoradiation
OS data were not yet mature at the time of the most recent study analysis, though no trend toward worsened survival with osimertinib was observed.
The most common adverse events from osimertinib—including laboratory abnormalities—that occurred in 20% or more of patients included lymphopenia, leukopenia, interstitial lung disease/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough, and COVID-19 infection.
References
1. FDA Release. FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy. Published: September 25, 2024. Accessed: September 25, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-locally-advanced-unresectable-stage-iii-non-small-cell-lung-cancer?utm_medium=email&utm_source=govdelivery
2. Lu S, Kato T, Dong X, et al. Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. New Eng J Med. 2024;391:585-597. doi:10.1056/NEJMoa2402614.
FDA Approves Encorafenib Plus Cetuximab and Chemo in BRAF V600E-Positive Metastatic CRC
Published: December 20th 2024 | Updated: December 20th 2024The FDA has granted approval for the use of encorafenib in combination with cetuximab and mFOLFOX6 for the treatment of metastatic colorectal cancer harboring a BRAF V600E mutation.
