Merck, Daiichi pull US application for second partnered cancer therapy
MRK•Merck and Daiichi Sankyo withdrew their US application for accelerated approval of experimental lung cancer therapy ifinatamab deruxtecan after the FDA determined mid-stage study data did not meet requirements. Enrollment is nearly complete in a larger late-stage trial.
1. Application withdrawn
The companies withdrew their application seeking accelerated approval for ifinatamab deruxtecan, which was under review for adults with extensive-stage small cell lung cancer whose disease had worsened after standard chemotherapy. They said the decision followed discussions with the FDA, which determined that data from a mid-stage study did not support an early approval.
2. Further testing planned
This is the second of three antibody-drug conjugates developed under the companies’ 2023 partnership, worth up to $22 billion, to face a US application withdrawal. The companies said they would continue evaluating ifinatamab deruxtecan; enrollment is nearly complete in a late-stage trial comparing it with standard chemotherapy options, with results intended to support approval applications in the US and elsewhere. The therapy is also being tested in late-stage trials for advanced prostate and esophageal cancers.
