The US Food and Drug Administration (FDA) has approved the use of osimertinib (Tagrisso, AstraZeneca Pharmaceuticals), a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in certain adult patients.
Specifically, the approval is for patients whose disease has not progressed during or after concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations. These EGFR mutations can be detected by an FDA-approved test.
The FDA had previously approved osimertinib in combination with platinum-based chemotherapy as a first-line treatment for patients with locally advanced or metastatic NSCLC with the same EGFR mutations. The EGFR-TKI also carries other indications, including as first-line monotherapy for locally advanced or metastatic EGFR-mutated NSCLC.
The latest approval was based on findings from the randomized, placebo-controlled LAURA trial, which demonstrated improved median progression-free survival with osimertinib compared to placebo (39.1 vs 5.6 months; hazard ratio, 0.16). Overall survival results were still immature, but no trend towards a detriment was observed.
The most common adverse reactions reported in the study were lymphopenia, leukopenia, interstitial lung disease/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough, and COVID-19 infection.
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by Sharon Worce... a las www.medscape.com 09-27-2024
https://www.medscape.com/viewarticle/fda-okays-osimertinib-after-crt-locally-advanced-2024a1000hjdConsultas más profundas