Merck, Daiichi Sankyo withdraw US application for lung cancer therapy
MRK•Merck and Daiichi Sankyo voluntarily withdrew their US application seeking accelerated approval for experimental lung cancer therapy ifinatamab deruxtecan. The FDA determined data from a mid-stage study did not meet requirements for an early approval.
1. Application withdrawn
Merck and Daiichi Sankyo voluntarily withdrew their US application for accelerated approval of ifinatamab deruxtecan after discussions with the FDA. The agency determined that data from a mid-stage clinical study did not satisfy requirements for an early approval.
2. Treatment under review
The therapy was being reviewed for adults with extensive-stage small cell lung cancer whose disease had worsened after standard chemotherapy.
