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Daiichi Sankyo and Merck & Co/MSD Withdraw BLA for Ifinatamab Deruxtecan...

Daiichi Sankyo and Merck & Co/MSD have voluntarily withdrawn the Biologics License Application (BLA) for ifinatamab deruxtecan (I-DXd; DS-7300a), a B7-H3-directed antibody-drug conjugate (ADC), for adults with previously treated extensive-stage small cell lung cancer (ES-SCLC). The withdrawal follows discussions with the U.S. Food and Drug Administration (FDA), which concluded that the data submitted with the application, including results from the Phase 2 IDeate-Lung01 trial, did not satisfy the requirements for accelerated approval in the proposed indication.

Risvutatug Rezetecan Demonstrates Overall Survival Benefit Over Topotecan in Relapsed Small...

Interim results from the pivotal Phase 3 ARTEMIS-008 trial (NCT06498479) show that risvutatug rezetecan, a B7-H3-directed antibody-drug conjugate, significantly reduced the risk of death...

B7-H3 Antibody-Drug Conjugates Gain Momentum as Frontline Standards Shift Across Solid...

B7-H3 Antibody-Drug Conjugates Gain Momentum as Frontline Standards Shift Across Solid Tumors

Ifinatamab Deruxtecan Receives FDA Priority Review for Previously Treated Extensive-Stage Small...

Ifinatamab Deruxtecan (previously known as DS-7300a), a B7-H3-directed antibody-drug conjugate being developed by Daiichi Sankyo and Merck & Co. (known as MSD outside of the United States and Canada), could offer a First-in-Class option for patients diagnosed with extensive-stage small cell lung cancer (ES-SCLC) following platinum-based chemotherapy.

11th World ADC Awards 2024: Celebrating a Decade of Excellence

Earlier this week, during the 15th World ADC in San Diego, CA, the 11th World ADC Awards reunited both newcomers and leaders of the...

Merck & Co/MSD and Daiichi Sankyo to Jointly Development and Commercialization...

Merck & Co (known as MSD outside of the United States and Canada) and Daiichi Sankyo have entered into a global development and commercialization agreement for the jointly development of three of Daiichi Sankyo’s DXd antibody-drug conjugate (ADC) candidates.  The selected ADCs include patritumab deruxtecan (U3-1402/HER3-DXd), ifinatamab deruxtecan (DS-7300a/I-DXd) and raludotatug deruxtecan (DS-6000a/R-DXd).

World ADC 2023 London – What to Expect

With renewed focus and commitment in creating a platform for innovative scientific insights and transformative experiences, 13th World ADC in London, held March 13...