The US FDA has accepted and granted Priority Review for ifinatamab deruxtecan (I-DXd), developed by Daiichi Sankyo and Merck for the treatment of adults with extensive-stage small cell lung cancer.
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of October 10, 2026, when it will decide whether to approve the therapy.
If approved, ifinatamab deruxtecan could become a first-in-class B7-H3 directed DXd antibody drug conjugate (ADC), a targeted cancer therapy discovered by Daiichi Sankyo and jointly developed with Merck.
The application is supported by data from the Phase 2 IDeate-Lung01 study, with additional backing from the Phase 1/2 IDeate-PanTumor01 trial. The drug had previously received FDA Breakthrough Therapy Designation in August 2025 for the same patient population.
The FDA is also reviewing the application under its Real-Time Oncology Review (RTOR) program and Project Orbis—initiatives designed to speed up the evaluation of promising cancer therapies by enabling early data review and coordinated international assessment.
“The FDA’s granting of Priority Review for ifinatamab deruxtecan marks a significant milestone in our effort to provide new and innovative treatment options for patients with extensive-stage small cell lung cancer,” said John Tsai, global head, R&D, Daiichi Sankyo.
“We look forward to continuing to work with the FDA to bring this potential first-in-class B7-H3 directed DXd antibody drug conjugate to patients as quickly as possible.”
“Small cell lung cancer remains one of the toughest cancers to treat, with few options if the disease progresses after standard of care treatments,” said Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories.
“The FDA’s acceptance of the BLA reinforces the important role that ifinatamab deruxtecan could play in helping to address the needs of patients with extensive-stage small cell lung cancer.”
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