AstraZeneca must 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. The move will delay the drug’s market launch and raise questions about how widely it could be used.

The drug datopotamab deruxtecan, or Dato-DXd, is a type of next-generation chemotherapy, a so-called antibody-drug conjugate, in which AstraZeneca and other companies have invested. AstraZeneca, which is partnering with Daiichi Sankyo on the drug, has named Dato-DXd as one of the products that will help the company meet its goal of nearly doubling its sales to $80 billion by 2030.

Based on the results of the Tropion-Lung01 trial, the companies applied to the Food and Drug Administration in February for approval of Dato-DXd for the treatment of advanced non-squamous non-small cell lung cancer. (They have also sought approval for a form of breast cancer.) However, full trial data released in September showed that Dato-DXd did not outperform standard chemotherapy in terms of overall survival.