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 ...

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

The first patient has been dosed in a global Phase II study assessing Hepzato in combination with trifluridine-tipiracil and bevacizumab for liver-dominant metastatic colorectal cancer, with primary ...

Results from the Phase II OptiTROP-Lung01 trial (NCT05351788) showed that Sichuan Kelun-Biotech’s sac-TMT combined with ...

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 ...

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 ...

Rahway: Merck and Daiichi Sankyo have announced that Ifinatamab deruxtecan (I-DXd) has been granted Breakthrough Therapy ...

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

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

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 ...