Datopotamab deruxtecan

Daiichi Sankyo and AstraZeneca withdrew a marketing authorization application for datopotamab deruxtecan (Dato-DXd) in advanced nonsquamous non–small cell lung cancer (NSCLC) in the EU, based on EMA feedback. A new BLA was submitted for EGFR-mutated NSCLC patients. Data from the TROPION-Lung01 trial showed Dato-DXd had a median OS of 12.9 months vs 11.8 months for docetaxel, with a median PFS of 4.4 months vs 3.7 months, and lower rates of adverse effects.

AstraZeneca and Daiichi Sankyo withdrew their EU marketing authorization application for datopotamab deruxtecan (Dato-DXd) in non-squamous non-small cell lung cancer, following EMA's CHMP feedback. The TROPION-Lung01 trial met progression-free survival but not overall survival.

AstraZeneca and Daiichi Sankyo withdrew the EU marketing authorization application for datopotamab deruxtecan in nonsquamous non-small cell lung cancer, based on EMA feedback. They remain committed to its development in lung cancer and continue the review for hormone receptor-positive, HER2-negative metastatic breast cancer.

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 and Daiichi Sankyo withdrew the EU marketing application for their lung cancer therapy, datopotamab deruxtecan, based on late-stage trial data and feedback.

Daiichi Sankyo and AstraZeneca withdrew the EU MAA for datopotamab deruxtecan (Dato-DXd) in NSCLC, based on EMA feedback. They remain committed to its development in lung cancer and other settings.

AstraZeneca and Daiichi Sankyo withdrew their EU marketing application for datopotamab deruxtecan for advanced nonsquamous non-small cell lung cancer due to EMA feedback, but remain committed to its development through ongoing trials.

AstraZeneca and Daiichi Sankyo withdrew their Dato-DXd registration for non-small-cell lung cancer treatment in Europe, citing CHMP exchanges. Dato-DXd showed significant progression-free survival improvement in Phase III trials. HER2-negative metastatic breast cancer registration remains under review. AstraZeneca shares rose 0.5% despite the withdrawal.

AstraZeneca and Daiichi Sankyo withdrew their EU marketing application for datopotamab deruxtecan in nonsquamous NSCLC, based on CHMP feedback. They remain committed to making it available for lung cancer patients in the EU through ongoing clinical trials.