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