LONDON — AstraZeneca said Tuesday it has had to resubmit a closely watched medicine for U.S. approval in a different form of lung cancer, a step that will delay the drug’s arrival on the market and that will add to questions about how widely it could be used.
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The medicine, datopotamab deruxtecan, or Dato-DXd, is a type of next-generation chemotherapy called an antibody-drug conjugate that AstraZeneca and other companies have been pouring investments into. AstraZeneca, which is partnered with Daiichi Sankyo on the drug, has cited Dato-DXd as one of the products that will help it achieve its goal of nearly doubling its revenue to $80 billion by 2030.
The companies filed Dato-DXd for Food and Drug Administration approval in February for advanced nonsquamous non-small cell lung cancer, based on the results of the Tropion-Lung01 trial. (They’ve also filed for approval in a form of breast cancer.) But full trial data published in September showed Dato-DXd did not outperform standard chemotherapy on overall survival.
