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Ifinatamab Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Small Cell Lung Cancer
_↗ merck.com
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Daiichi Sankyo and Merck have announced that their investigational medicine, ifinatamab deruxtecan (I-DXd), has received a Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for treating adults with extensive-stage small cell lung cancer (SCLC) that has progressed after platinum-based chemotherapy. This is the first BTD for I-DXd and the 14th overall for Daiichi Sankyo's oncology portfolio. The FDA’s BTD program is designed to expedite the development and review of new drugs for serious conditions that show a substantial improvement over existing treatments. This designation was based on promising data from the Phase 2 IDeate-Lung01 trial, with additional supporting data from the Phase 1/2 IDeate-PanTumor01 trial.

I-DXd is a B7-H3 directed DXd antibody-drug conjugate (ADC), a potential first-in-class medicine developed in a collaboration between Daiichi Sankyo and Merck. B7-H3 is a protein often overexpressed in various cancers, including SCLC, and its presence is linked to a poor prognosis.

The I-DXd compound is engineered using Daiichi Sankyo's proprietary DXd ADC technology, which uses a specific linker to deliver a potent topoisomerase I inhibitor payload directly to cancer cells. This targeted approach aims to provide a new, more effective treatment option for patients with this aggressive disease. Both companies emphasized the urgent need for new therapies for SCLC, particularly for patients who have exhausted standard treatment options.

The IDeate-Lung01 trial, a global, two-part Phase 2 study, enrolled 187 patients to evaluate the safety and effectiveness of I-DXd. Its primary goal was to measure the objective response rate, with key secondary endpoints including progression-free survival and overall survival. The results of the primary analysis from this trial will be presented at the IASLC 2025 World Conference on Lung Cancer. The supporting IDeate-PanTumor01 trial is a global, first-in-human Phase 1/2 study that assessed the safety and efficacy of I-DXd in a broader range of solid tumors. This ongoing research demonstrates the companies' commitment to advancing this new medicine and expanding their clinical development programs to explore its potential in other cancer types.

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