Daiichi Sankyo Co Ltd. has experienced yet another setback with its quizartinib NDA submission, as the U.S. FDA has now extended the review period by three months to July 24, 2023, to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies.
Daiichi Sankyo Co Ltd. has experienced yet another setback with its quizartinib NDA submission, as the U.S. FDA has now extended the review period by three months to July 24, 2023, to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies. No additional efficacy or safety data has been requested.
Mutations in fms-related receptor tyrosine kinase 3 (FLT3) are related to the increase of reactive oxygen species (ROS) in acute myeloid leukemia (AML). Recent studies suggest that by regulating ROS production and antioxidant expression, oncogenes such as FLT3 directly influence leukemia progression, even during anticancer therapy.
Function Oncology Inc. emerged from stealth on April 12 with the announcement of a $28 million series A financing that will continue support development of its CRISPR-enabled platform to profile cancer in patient-specific detail. The platform goes beyond next-generation sequencing to measure gene function, potentially allowing identification of new therapeutic targets and better matching of available therapies to vulnerabilities in an individual’s tumors.
Cancer treatment developer Apollomics Inc. merged with special purpose acquisition company (SPAC) Maxpro Capital Acquisition Corp., gaining a listing on Nasdaq under the ticker APLM and raising $23.65 million of private investment in public equity (PIPE).
Two molecules that affected the cell cycle only of acute myeloid leukemia (AML) cells could be used as a clinical strategy against this pathology. Scientists at Memorial Sloan Kettering Cancer Center and Harvard University have discovered that DEG-35 and DEG-77 arrested the cell cycle and promoted cell differentiation and apoptosis in these cells.
If clinical efforts pan out, gamma delta T-cell specialist TC Biopharm plc could plant the space’s first U.S. regulatory flag. Founded 10 years ago, the Glasgow, U.K.-based firm is marching ahead with phase IIb work testing main asset Omnimmune, an allogeneic unmodified cell therapy, in acute myeloid leukemia (AML).
