GlycoMimetics announced the U.S. Food and Drug Administration FDA cleared the addition of a protocol amendment to the company’s pivotal Phase 3 study of uproleselan for relapsed/refractory R/R Acute Myeloid Leukemia AML . The amendment will allow a time-based analysis of the primary endpoint of overall survival to be conducted following a defined cutoff date if the 295 survival events originally planned for an event driven analysis have not been observed. With the addition of a time-based analysis, topline results are expected to be reported by the end Q2 2024. “We are pleased the FDA cleared the addition of a time-based pathway to final analysis as it provides the opportunity to evaluate the effect of uproleselan on R/R AML based on a clinically mature database with more than three years median follow-up,” said Harout Semerjian, Chief Executive Officer of GlycoMimetics. “This approach is consistent with regulatory precedent adopted for a prior pivotal AML study for an approved drug and reflects our commitment to science-driven analysis as we seek to deliver uproleselan to R/R AML patients in need of new treatment options as soon as possible.”…As part of the protocol amendment, the FDA also cleared the addition of landmark EFS and overall survival analyses as secondary endpoints.
Published first on TheFly
