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The EC has approved Hansoh Pharmaceutical’s Aumseqa (aumolertinib mesylate tablets), marketed as Ameile in China, for use as monotx. in adult pts with advanced NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations in the 1L therapy, and for advanced EGFR T790M mutation-positive NSCLC
Aumseqa is an oral, third-generation EGFR tyrosine kinase inhibitor (TKI) that selectively targets mutated EGFR to inhibit tumor cell growth and reduce the spread of EGFR-mutated lung cancer, while…
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The US FDA has granted RMAT Designation to KB707 for the treatment of advanced or metastatic NSCLC
Designation was supported by the ongoing P-I/II (KYANITE-1) trial assessing KB707 (administered via nebulization) across 7 cohorts: Arms 1-4 as monotx., Arm 5 with Keytruda, Arm 6 with Keytruda & CT & Arm 7 with CT alone…
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The US FDA has accepted NDA & granted priority review to oveporexton (TAK-861) for the treatment of NT1, with PDUFA goal date in Q3’26
NDA was supported by robust clinical data, incl. global P-III (FirstLight & RadiantLight) trials assessing oveporexton in NT1 pts
Oveporexton showed objective and patient-reported improvements in wakefulness, EDS, cataplexy, attention,…
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The Chinese NMPA has accepted the application of Arexvy RSV vaccine for the prevention of LRTD caused by respiratory syncytial virus (RSV) in adults aged ≥60yrs.; regulatory decision is expected by 2027
Submission was based on extensive clinical data, incl. results from the P-III trial assessing safety & immunogenicity of Arexvy in adults (≥60yrs.)…
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The US FDA has accepted sBLA & granted priority review to Hympavzi for the treatment of pts (≥6yrs.) with hemophilia A or B with inhibitors & in pts (6-11yrs.) with hemophilia A or B without inhibitors (PDUFA: Q2’26)
sBLA for Hympavzi (SC, QW) in adults & adolescents was supported by data from the inhibitor…
Akeso’s Ivonescimab + CT Receives the NMPA Breakthrough Therapy Designation for Biliary Tract Cancer
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The Chinese NMPA has granted BTD to ivonescimab + CT for the 1L treatment of advanced biliary tract cancer (BTC)
Ivonescimab is being assessed in the fully-enrolled P-III (AK112-309/HARMONi-GI1) in combination with CT for the 1L treatment of advanced BTC
The P-Ib/II trial data presented at ASCO 2024 showed ivonescimab plus CT showed an…
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The Chinese NMPA has approved sacituzumab tirumotecan for the treatment of adults with unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine therapy & ≥1L of CT in an advanced setting
Approval was based on the P-III (OptiTROP-Breast02) trial assessing sac-TMT vs CT for the…
GSK Reports the EC Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)
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The EC has approved Nucala as an add-on maintenance treatment of adults with uncontrolled COPD characterised by raised blood eosinophils phenotype on a combination of an inhaled corticosteroid, a long-acting beta2-agonist (LABA), & a long-acting muscarinic antagonist
Approval was based on the P-III (MATINEE) trial assessing Nucala (100mg, SC, Q4W; n=403) vs PBO (n=401)…
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The US FDA has accepted NDA of zanzalintinib + Tecentriq (atezolizumab) for the treatment of adults with mCRC who have been previously treated with fluoropyrimidine, oxaliplatin & irinotecan-based CT, &, if RAS wild-type, an anti-EGFR therapy (PDUFA: Dec 03, 2026)
NDA was based on P-III (STELLAR-303) trial assessing zanzalintinib in combination with atezolizumab (n=451)…
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FDA has accepted sBLA & granted priority review to Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy (PDUFA: Q2’26)
sBLA was backed by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644 above-mentioned pts, which showed 5mos. improvement in…

