Merck and Daiichi win Breakthrough status for ifinatamab deruxtecan

Merck & Co (NYSE: MRK) and Daiichi Sankyo (TYO: 4568) have received Breakthrough Therapy designation from the US regulator for ifinatamab deruxtecan, a B7-H3 directed antibody-drug conjugate. The designation applies to adults with extensive-stage small cell lung cancer that has progressed following platinum-based chemotherapy.

The decision was supported by data from the phase II IDeate-Lung01 trial and the phase I/II IDeate-PanTumor01 study.

“This Breakthrough Therapy Designation granted by the FDA to ifinatamab deruxtecan highlights the urgent need for new treatment options for patients with pretreated extensive-stage small cell lung cancer,” said Ken Takeshita, global head of R&D at Daiichi Sankyo. Merck’s chief medical officer Eliav Barr added that the recognition “reinforces our confidence in the promise” of the therapy.