Swedish pharmaceutical company Immedica Pharma AB said on Friday that the Zepzelca (lurbinectedin) + Tecentriq (atezolizumab) maintenance regimen is now approved by the Emirates Drug Establishment for adults in the United Arab Emirates with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy.
The approval follows results from the Phase 3 IMforte trial, which showed a 46% reduction in risk of disease progression or death and a 27% reduction in risk of death when compared with atezolizumab maintenance alone. Results showed a median overall survival of 13.2 months versus 10.6 months (stratified HR 0.73; 95% CI: 0.57–0.95; p=0.0174) and progression-free survival by independent assessment of 5.4 months vs 2.1 months (stratified HR 0.54; 95% CI: 0.43–0.67; p
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