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AstraZeneca to resubmit closely watched cancer drug to FDA
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AstraZeneca to resubmit closely watched cancer drug to FDA

LONDON — AstraZeneca said Tuesday it had to resubmit a closely watched drug for U.S. approval for a different form of lung cancer, a step that will delay the drug’s arrival on the market and add to questions on the extent of its use.

The drug, datopotamab deruxtecan, or Dato-DXd, is a type of next-generation chemotherapy called an antibody-drug conjugate that AstraZeneca and other companies have invested in. AstraZeneca, which is partnering with Daiichi Sankyo on the drug, cited Dato-DXd as one of the products that will help it achieve its goals. its objective of almost doubling its turnover to $80 billion by 2030.

Companies filed Dato-DXd for Food and Drug Administration approval in February for advanced non-squamous non-small cell lung cancer, based on the results of the Tropion-Lung01 trial. (They have also filed for approval in a form of breast cancer.) But the full trial data published in September showed that Dato-DXd did not outperform standard chemotherapy in terms of overall survival.

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