AstraZeneca: priority review in US for Dato-DXd

(CercleFinance.com) - AstraZeneca announced on Monday that the US FDA has granted priority review to a bronchial cancer treatment developed with Japan's Daiichi Sankyo.


The product is datopotamab deruxtecan (Dato-DXd), an antibody-drug conjugate targeting EGFR-mutated non-small cell lung cancer, a disease considered difficult to treat.

This type of cancer affects between 10% and 15% of non-small cell lung cancer patients in the USA and Europe, and 30% to 40% in Asia.

A "priority review" means that the FDA aims to rule on an application for approval within six months, compared with 10 months for a standard review. The US agency's decision is therefore expected on 12 July.

AstraZeneca says that datopotamab deruxtecan (Dato-DXd) is intended to offer patients an effective and better-tolerated alternative to conventional chemotherapy.


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