Confirmatory Trial

Boehringer Ingelheim breaks into oncology as FDA grants accelerated approval to Hernexeos (zongertinib) for HER2 TKD–mutated NSCLC

2 weeks ago talkbio0Tagged Accelerated, Approved, Beamion, Boehringer Ingelheim, competition, Confirmatory Trial, Enhertu, erbB-2 Receptor, Frequency of Responses, HER2-mutant, Hernexeos, Identifier, LUNG-1, Mutation, Non-Small Cell Lung Carcinoma, non-squamous NSCLC, Oncomine Dx Target Test, oral targeted therapy, Priority Review, Requirement, TKD, United States Food and Drug Administration, Zongertinib

Boehringer Ingelheim; Hernexeos; zongertinib; FDA approval; accelerated approval; non-squamous NSCLC; HER2 TKD mutations; Oncomine Dx Target Test; Beamion LUNG-1; objective response rate; first oral targeted therapy for HER2-mutant NSCLC; priority review; breakthrough therapy designation; confirmatory trial requirement; competition with Enhertu

FDA Grants Accelerated Approval to Jazz’s Dordaviprone (Modeyso), the First Treatment for Ultra-Rare Brain Tumor

2 weeks ago talkbio0Tagged Accelerated, Approved, Brain Neoplasms, Chimerix acquisition, Confirmatory Trial, Dordaviprone, midline glioma, Modeyso, pediatric brain cancer, United States Food and Drug Administration

Dordaviprone; Modeyso; FDA approval; H3 K27M-mutant diffuse midline glioma; ultra-rare brain tumor; Jazz Pharmaceuticals; accelerated approval; pediatric brain cancer; Chimerix acquisition; confirmatory trial

BMS Details Confirmatory Trial Win for KRAS Inhibitor Krazati

1 year ago talkbio0Tagged Accelerated, Approved, Confirmatory Trial, Inhibitor, K-ras Oncogene, KRAZATI, Myers, Non-Small Cell Lung Carcinoma, Pharmacotherapy, Progression-Free Survival, squibb, United States Food and Drug Administration

Bristol Myers Squibb, Krazati, KRAS inhibitor, confirmatory trial, non-small cell lung cancer (NSCLC), progression-free survival (PFS), chemotherapy, accelerated approval, FDA

NS Pharma’s Duchenne Muscular Dystrophy Therapy Viltepso Fails Confirmatory Trial

1 year ago talkbio0Tagged Approved, Clinical Research, Confirmatory Trial, Duchenne, Muscular Dystrophy, nanosecond, Pharma, Phase III, RACER53, United States Food and Drug Administration, Viltepso

NS Pharma, Viltepso, Duchenne Muscular Dystrophy, Confirmatory Trial, Phase III, RACER53 Study, FDA Approval

NS Pharma’s Viltepso Fails Confirmatory Phase III Trial for Duchenne Muscular Dystrophy Treatment

1 year ago talkbio0Tagged Approved, Clinical Research, Confirmatory Trial, Muscular Dystrophy, Duchenne, nanosecond, Pharma, Phase 3 Clinical Trials, RACER53, United States Food and Drug Administration, Viltepso

Viltepso, NS Pharma, Duchenne muscular dystrophy, RACER53 study, viltolarsen, FDA approval, confirmatory trial, phase III trial, DMD treatment

Bristol Myers Squibb’s KRAZATI Confirmed Effective in Pivotal Phase 3 KRYSTAL-12 Trial Following Accelerated Approval

1 year ago talkbio0Tagged Accelerated Approval, adagrasib, Approved, bristol-myers, Clinical Benefit, Confirmatory Trial, Continuous, June 21/ 2024, KRASG12C mutation, KRAZATI, KRYSTAL-12, Locally, Metastatic to, Non-Small Cell Lung Carcinoma, ORR, Overall response rate, PDUFA, Primary Endpoint, Progression-Free Survival, squibb, United States Food and Drug Administration, Verification of Theories

Bristol Myers Squibb, KRAZATI (adagrasib), Pivotal Phase 3 trial, KRYSTAL-12 study, Primary endpoint met, Progression-free survival (PFS), Overall response rate (ORR), Confirmatory trial, Non-small cell lung cancer (NSCLC), Locally advanced or metastatic, KRASG12C mutation, Accelerated approval, Continued approval contingent on clinical benefit verification, FDA assigned PDUFA goal date of June 21/ 2024