BL-M11D1
- Generic Name
- BL-M11D1
FDA Actions in October 2024 Accelerate Oncology Treatment Advances
• The FDA granted priority review to fam-trastuzumab deruxtecan-nxki (T-DXd) for HER2-low/ultra-low breast cancer, potentially expanding treatment options for this patient subgroup.
• Acalabrutinib (Calquence) was approved for frontline mantle cell lymphoma (MCL), offering a new first-line treatment option for patients with this aggressive lymphoma.
• The FDA approved zolbetuximab (Vyloy) for HER2-negative gastric or gastroesophageal junction adenocarcinoma, marking progress in treating this challenging cancer type.
• Asciminib (Scemblix) received accelerated approval for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia, providing a novel treatment approach.
FDA Clears IND for SystImmune's BL-M11D1 in Relapsed/Refractory AML
• The FDA has cleared SystImmune's Investigational New Drug (IND) application for BL-M11D1, an antibody-drug conjugate (ADC), for relapsed/refractory Acute Myeloid Leukemia (AML).
• BL-M11D1 targets CD33, a protein expressed on myeloid cells, and is designed to trigger antibody-dependent cellular cytotoxicity (ADCC) and induce tumor cell death.
• A Phase 1 clinical trial, BLM11D1-HM-101, is set to begin in the United States to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BL-M11D1.
• BL-M11D1 comprises a monoclonal antibody binding CD33 and a topoisomerase I inhibitor payload, potentially offering a novel therapeutic option for AML patients.
Drug Development Updates
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