Datopotamab deruxtecan

Daiichi Sankyo and AstraZeneca withdrew their EU marketing application for datopotamab deruxtecan (Dato-DXd) for NSCLC treatment, following EMA feedback. They remain committed to its development for lung cancer, with ongoing trials. Dato-DXd, a TROP2 directed ADC, is part of a broad clinical program across multiple cancers.

AstraZeneca's stock fell 14% in three months due to China subsidiary investigations and sector-wide downturns. Despite challenges, it boasts 12 blockbuster drugs, with oncology leading 40% of revenues. AstraZeneca aims for 25 blockbusters by 2030, focusing on innovation and new technologies, despite recent setbacks and China's VBP impact on Farxiga.

2024 saw key FDA approvals, including a new schizophrenia treatment and a first in-class immunotherapy, but fell short of 2023's 55 novel nods. 2025 may see an uptick, with potential approvals for Vertex's non-opioid suzetrigine, Novo Nordisk's semaglutide for kidney and liver conditions, J&J's nipocalimab for myasthenia gravis, and AstraZeneca/Daiichi Sankyo's Enhertu for HER2-low breast cancer.

Daiichi Sankyo withdrew the marketing authorization application for datopotamab deruxtecan (Dato-DXd) for nonsquamous NSCLC treatment in the EU, based on EMA feedback from the TROPION-Lung01 trial, where Dato-DXd did not significantly improve overall survival compared to docetaxel.

Biotech companies await key FDA decisions in January 2025, including Atara Biotherapeutics' Tab-cel for EBV+ PTLD, Biogen's Leqembi for Alzheimer's, AstraZeneca's Datopotamab Deruxtecan for breast cancer, Vertex's Suzetrigine for acute pain, and Axsome's AXS-07 for migraine.

AstraZeneca and Daiichi Sankyo withdrew the EU marketing application for datopotamab deruxtecan for NSCLC treatment, based on EMA feedback. They remain committed to its development for lung and breast cancer, with ongoing trials. Datopotamab deruxtecan, a TROP2-directed ADC, showed significant PFS improvement in trials.

AstraZeneca and Daiichi Sankyo withdrew their EU marketing application for lung cancer drug datopotamab deruxtecan following EMA feedback. They remain committed to its development and availability, with ongoing trials and another application for breast cancer under EMA review.