Developed by Daiichi Sankyo and Merck, it treats patients with Pretreated Extensive-Stage Small Cell Lung Cancer.

Recent advancements in Merck's (MRK) product portfolio, including the FDA's Breakthrough Therapy Designation for ifinatamab deruxtecan and several approvals of their flagship drug KEYTRUDA, are ...

FDA designates ifinatamab deruxtecan as a breakthrough therapy for extensive-stage small cell lung cancer, promising improved ...

The FDA has granted Breakthrough Therapy designation to ifinatamab deruxtecan for the treatment of extensive-stage small cell lung cancer in pretreated patients.

Ifinatamab deruxtecan (I-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell ...

The FDA granted breakthrough therapy designation to Ifinatamab deruxtecan for some with extensive-stage small cell lung ...

Ifinatamab deruxtecan has been granted Breakthrough Therapy Designation by the FDA for the treatment of adult patients with extensive-stage small ...

Merck & Co (NYSE: MRK) and Daiichi Sankyo (TYO: 4568) have received Breakthrough Therapy designation from the US regulator ...

US FDA grants breakthrough therapy designation to Daiichi Sankyo & Merck’s ifinatamab deruxtecan for patients with pretreated extensivestage SCLC: Tokyo Tuesday, August 19, 2025 ...

Ifinatamab deruxtecan was granted orphan drug designation by the U.S. Food and Drug Administration in April 2023 and by the European Commission in February 2024 for the treatment of SCLC.

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to ifinatamab deruxtecan (I-DXd) for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC ...

Ifinatamab deruxtecan (I-DXd) is 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 ...