Pharma powerhouses Daiichi Sankyo and Merck have secured a major regulatory milestone, as the US FDA has accepted and granted Priority Review to their application for ifinatamab deruxtecan in extensive-stage small cell lung cancer.
The application targets adult patients with extensive-stage small cell lung cancer whose disease has progressed following platinum-based chemotherapy.
The investigational therapy, ifinatamab deruxtecan, is a potential first-in-class B7-H3 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed with Merck.
The submission is supported by data from the IDeate-Lung01 Phase 2 trial, with additional evidence from the IDeate-PanTumor01 Phase 1/2 study.
Ifinatamab deruxtecan had already been granted Breakthrough Therapy Designation in August 2025 for the same patient population.
“This is a significant regulatory step forward for the program,” the companies said in highlighting the FDA’s decision.
“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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