Question · Q3 2025
Sudan Loganison asked whether a broad label for colorectal cancer, encompassing both ITT and non-liver metastases (NLM) subgroups, could be expected with the planned NDA submission by year-end 2025, or if a rolling submission would be necessary. He also asked if regulatory guidance influenced the decision to split the subgroups.
Answer
Dana Aftab, Executive Vice President of Research and Development, clarified that the company intends to file based on the positive results from the ITT population, which is the entire trial population, and expects this to provide the broadest label. She noted that the NLM subgroup is a second dual primary endpoint, and the filing will proceed based on the ITT data.
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