USFDA places partial clinical hold on Magrolimab studies in acute myeloid leukemia: Gilead Sciences
Magrolimab is a potential first-in-class investigational anti-CD47 immunotherapy.;
Foster City: Gilead Sciences, Inc. has announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the initiation of new patients in U.S. studies evaluating magrolimab to treat acute myeloid leukemia (AML).
The FDA action follows the previously announced discontinuation of the Phase 3 ENHANCE study of magrolimab in higher-risk myelodysplastic syndromes (HR-MDS).
Read also: Gilead to discontinue Phase 3 ENHANCE study of Magrolimab plus Azacitidine in higher-risk MDS
Effective immediately, screening and enrollment of new study participants under the U.S. investigational new drug application (IND 147229) and U.S. Expanded Access Program will be paused. Patients already enrolled in AML clinical studies may continue to receive treatment and be monitored, according to the current study protocol. Global regulatory authorities and clinical trial investigators involved in the studies have been informed of the FDA’s decision. Studies of magrolimab in solid tumors continue without any impact from the FDA action.
Gilead Sciences is a biopharmaceutical company with headquarters in Foster City, California. The company operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.