On 13 April 2026, Daiichi Sankyo announced that the FDA has accepted for priority review a Biologics License Application (BLA) for Daiichi Sankyo/MSD’s ifinatamab deruxtecan (I-DXd) for the treatment of extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Ifinatamab deruxtecan was granted Breakthrough Therapy Designation by the FDA for the same indications in August 2025.
The FDA review of the BLA is being conducted under Project Orbis, an initiative of the FDA’s Oncology Center of Excellence that provides a framework for the collaborative review of new cancer treatments among international regulatory partners. It is also being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program, which facilitates earlier submission of topline efficacy and safety results, prior to the submission of the complete application, to support an earlier start to the FDA’s evaluation of the application.
In October 2023, Daiichi Sankyo and MSD entered into a global development and commercialisation collaboration for three of Daiichi’s deruxtecan antibody-drug conjugates (ADCs), including ifinatamab deruxtecan. Under that agreement, Daiichi and MSD agreed to jointly develop and commercialise the ADCs around the world, excluding Japan where Daiichi retains exclusive commercialisation rights. Daiichi is solely responsible for manufacture and supply of the products.