Pre-Scheduled Post: Daiichi Sankyo And Merck… Cranking Out Promising New Cancer Approaches — FDA Breakthrough Designation, For Ifinatamab Deruxtecan.

Until I get back on-grid later tonight, here’s a story I preloaded — earlier, on Monday. It is good (but immaterial) news for immuno-candidate ifinatamab deruxtecan, a B7-H3 directed antibody-drug conjugate — in certain small cell lung cancers.

The Daiichi Sankyo / Merck relationship (of ~$9.5 billion, and rising) continues to bear immuno-onclological candidate fruit, thus ($$ subs. req.):

…Merck & Co and Daiichi Sankyo 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….

Now you know. Onward, and back in the saddle by morning — if not late night, tonight.

नमस्ते