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# Daiichi Sankyo and Merck Withdraw BLA for Lung Cancer
- URL: https://www.fdaweb.com/daiichi-sankyo-and-merck-withdraw-bla-for-lung-cancer/
- Published: 2026-09-29T00:16:00.000Z
- Updated: 2026-09-29T01:07:49.000Z
- Author: David McFarland
- Tags: Biologics

Daiichi Sankyo and Merck have withdrawn a BLA seeking accelerated approval for ifinatamab deruxtecan (I-DXd) for treating adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The action was based on input from FDA indicating that “data supporting the application, including from the [IDeate-Lung01](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT05280470&esheet=54610820&newsitemid=20260925284187&lan=en-US&anchor=IDeate-Lung01&index=1&md5=6b155da76548fa9ad7b7c79378ba5a08&ref=fdaweb.com) Phase 2 trial, do not satisfy requirements needed to support an accelerated approval for the proposed indication,” the companies say.

Daiichi Sankyo and Merck note that patient enrollment is continuing in the [IDeate-Lung02](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT06203210&esheet=54610820&newsitemid=20260925284187&lan=en-US&anchor=IDeate-Lung02&index=2&md5=a363b877009ef66fb6612cabd0d303da&ref=fdaweb.com) Phase 3 trial evaluating ifinatamab deruxtecan versus treatment of physician’s choice of chemotherapy (amrubicin, lurbinectedin or topotecan) in patients with relapsed ES-SCLC. “Enrollment into the IDeate-Lung02 Phase 3 trial is near completion and we look forward to assessing the potential for a future filing of ifinatamab deruxtecan with the FDA and other global regulatory authorities based on those results,” they say.

Additionally, there are two additional Phase 3 trials underway with ifinatamab deruxtecan in advanced/metastatic disease, including [IDeate-Prostate01](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT06925737&esheet=54610820&newsitemid=20260925284187&lan=en-US&anchor=IDeate-Prostate01&index=3&md5=09dec759d57ea3d559b5fe367db5790a&ref=fdaweb.com) for castration-resistant prostate cancer and [IDeate-Esophageal01](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT06644781&esheet=54610820&newsitemid=20260925284187&lan=en-US&anchor=IDeate-Esophageal01&index=4&md5=e7f4c8a3a661a3e289e719c761843f41&ref=fdaweb.com) for esophageal squamous cell carcinoma.

Ifinatamab deruxtecan is described as an investigational potential first-in-class B7-H3 directed ADC. “Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers,” according to the companies.