Kernekoncepter
The FDA has approved the use of osimertinib, a third-generation EGFR tyrosine kinase inhibitor, for the treatment of locally advanced, unresectable non-small cell lung cancer in certain adult patients.
Resumé
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.
Statistik
Median progression-free survival with osimertinib: 39.1 months
Median progression-free survival with placebo: 5.6 months
Hazard ratio for progression-free survival: 0.16
Citater
"The FDA approved osimertinib in combination with platinum-based chemotherapy as first-line treatment for patients with locally advanced or metastatic NSCLC with the same mutations in February."
"Overall survival results were immature at the most recent analysis, but 'no trend towards a detriment was observed,' with 36% of prespecified deaths for the final analysis reported, according to an FDA press release."