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In rectal cancer chemoradiotherapy and metastatic renal cell carcinoma combinations, CRLX101 has produced signals consistent with vascular normalization and radiosensitization, although randomized trials have so far shown mixed results for hard outcomes such as progression-free survival [91, 92]

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Novo submitted the drug to the US FDA in December 2025 based on the REDEFINE-1 and REDEFINE-2 trials

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