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
Curasight begins phase 1 trial of uTREAT in glioblastoma
Prestige Biopharma agrees Tuznue licence and supply deal for Latin America
Lunai Bioworks receives first LOI to license next-generation immune cell therapy
Active Biotech to receive US patent for tasquinimod formulation
AstraZeneca to invest USD2bn in major Maryland manufacturing expansion
Vaximm enters non-binding term sheet with BCM Europe
Hemispherian secures US patent allowance expanding GLIX1 patent protection
AbbVie receives approval for EPKINLY, rituximab and lenalidomide combination
Genentech reports first oral SERD to improve invasive disease-free survival in early breast cancer
Biotheryx completes enrolment in ongoing Phase 1a trial of BTX-9341 for HR+/HER2- breast cancer
Galmed Pharmaceuticals reports topline results for combination of Aramchol, Stivarga and metformin