Astra, Daiichi Withdraw EU Application for Lung Cancer Drug

(Bloomberg) — AstraZeneca Plc and Daiichi Sankyo Co. have voluntarily withdrawn an application for a lung cancer treatment in the European Union in a blow for the experimental drug. 

The two companies said Tuesday they had pulled the authorization request for Dato-DXd for some patients with non-squamous non-small cell lung cancer following feedback from the EU’s drug advisory committee. 

It comes after the duo published mixed results in September which showed that while the drug helped some people live longer, the results across all the patients in the trial were not statistically significant. Dato-DXd did show it can stave off the disease worsening for longer. 

Shares of Astra were little changed in early trading in London. The stock is down about 1% this year. 

The medicine, an antibody drug-conjugate whose full name is datopotamab deruxtecan, ferries a powerful chemotherapy directly to tainted cells to kill the cancer while sparing their healthy counterparts.

Astra and Daiichi Sankyo said they will continue to work to bring Dato-DXd to patients with lung cancer who can benefit in the EU. They added that they are still committed to the use of this drug for lung cancer and have “seven pivotal trials in various lung cancer settings” underway. 

The two companies EU application for Dato-DXd for the use of patients with hormone receptor (HR) positive, HER2-negative metastatic breast cancer remains under review.

In the US, Astra and Daiichi have submitted a new application for Dato-DXd for treatment of a smaller pool of lung cancer patients. 

–With assistance from Lisa Pham.

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