AstraZeneca

The article contains a PDF document with metadata, outlines, and page structures, including references to various elements such as fonts, images, and text.

AstraZeneca and Daiichi Sankyo submitted a new BLA for datopotamab deruxtecan targeting EGFR-mutated NSCLC, based on TROPION-Lung05 trial data. They withdrew a previous BLA for nonsquamous NSCLC. The decision followed FDA feedback. Results from TROPION-Lung05 and TROPION-Lung01 trials will be presented at ESMO Asia 2024.

AstraZeneca and Daiichi Sankyo withdrew the BLA for datopotamab deruxtecan in nonsquamous NSCLC, opting to submit a new BLA for EGFR-mutated NSCLC based on FDA feedback and trial results. The decision was informed by TROPION-Lung01 and TROPION-Lung05 trials, with new data to be presented at ESMO Asia 2024. Datopotamab deruxtecan, a TROP2-directed ADC, is under evaluation in ongoing Phase III trials for NSCLC treatment, including combinations with Tagrisso, aiming to validate biomarkers and improve patient outcomes.

Daiichi Sankyo and AstraZeneca submitted a new BLA for datopotamab deruxtecan targeting EGFR-mutated NSCLC, based on TROPION-Lung05 trial data. They withdrew a previous BLA for nonsquamous NSCLC. The decision followed FDA feedback, aiming to offer new hope for patients with challenging EGFR-mutated NSCLC.

Daiichi Sankyo and AstraZeneca submitted a new Biologics License Application for datopotamab deruxtecan targeting EGFR-mutated NSCLC, based on TROPION-Lung05 trial data. They withdrew a previous application for nonsquamous NSCLC. The decision followed FDA feedback, aiming to offer new hope for patients with challenging EGFR-mutated NSCLC.

Daiichi Sankyo and AstraZeneca submitted a new BLA for accelerated U.S. approval of datopotamab deruxtecan for EGFR-mutated NSCLC, based on TROPION-Lung05 trial data. Previously submitted BLA for nonsquamous NSCLC was withdrawn. The decision followed FDA feedback, aiming to offer new hope for patients with advanced EGFR-mutated NSCLC.

TROPION-Lung01 and TROPION-PanTumor01 trials assess datopotamab deruxtecan's efficacy and safety in advanced solid tumors. Primary endpoints include PFS and OS, with secondary endpoints like ORR and DOR. Over 1,500 patients globally are enrolled. Datopotamab deruxtecan, a TROP2-directed ADC, is part of AstraZeneca's ADC platform, with ongoing clinical trials across multiple cancers.

AstraZeneca and Amgen's TEZSPIRE showed significant reduction in nasal polyps and congestion in Phase III WAYPOINT trial for chronic rhinosinusitis with nasal polyps (CRSwNP), offering a potential new treatment option for patients.

AI In Precision Medicine Market to grow at a High CAGR from 2024-2031, driven by AI's ability to tailor treatments based on genetic, environmental, and lifestyle factors. Key players include IBM, Microsoft, AstraZeneca, and Siemens Healthineers. Market segments include technology, component, application, and region.

AstraZeneca and Amgen report positive phase 3 WAYPOINT trial results for Tezspire in chronic rhinosinusitis with nasal polyps, showing significant reduction in nasal polyps and congestion. Tezspire, targeting TSLP, offers a potential new treatment option for patients.