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

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 ...

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 ...

Merck MRK announced that the FDA has granted the Breakthrough Therapy designation (BTD) to its B7-H3-directed DXd ...

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.

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

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

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

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 ...