Izalontamab Brengitecan Receives U.S. FDA Breakthrough Therapy Designation Advanced EGFR-Mutated Non-Small Cell Lung Cancer
Izalontamab Brengitecan Receives U.S. FDA Breakthrough Therapy Designation Advanced EGFR-Mutated Non-Small Cell Lung Cancer
Belantamab Mafodotin Approved by US FDA for Treatment of Relapsed/Refractory Multiple Myeloma
The US Food and Drug Administration (FDA) has approved belantamab mafodotin (Blenrep®' GSK; see ADC Drugmap), an antibody-drug conjugate (ADC) comprising a humanized BCMA...
U.S. FDA Grants Fast Track Designation to ADCE-D01 for the Treatment of Soft...
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ADCE-D01 for the treatment of soft tissue sarcoma (STS).
AbbVie Submits Biologics License Application (BLA) to U.S. FDA for Pivekimab Sunirine
AbbVie has submitted a new Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of Pivekimab Sunirine, an investigational...
NICE Approves Enfortumab Vedotin + Pembrolizumab as First-line Treatment for Adults with Metastatic Urothelial...
NICE Approves Enfortumab Vedotin + Pembrolizumab as First-line Treatment for Adults with Metastatic Urothelial Cancer in the UK
Belantamab mafodotin Combinations Approved in EU for Treatment of Relapsed/refractory Multiple Myeloma
Belantamab mafodotin (Blenrep®; GSK), a humanised BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker, has been approved in the European Union (EU) for the treatment of adults with relapsed or refractory multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide
Daiichi Sankyo and Merck & Co/MSD Voluntarily Withdraw Biologics License Application (BLA) for Patritumab...
Daiichi Sankyo and Merck & CO/MSD have voluntarily withdrawn the Biologics License Application (BLA) seeking accelerated approval in the U.S. for patritumab deruxtecan (HER3-DXd) in patients with previously treated locally advanced or metastatic EGFR-mutated Non-Small Cell Lung Cancer (NSCLC) previously treated with two or more systemic therapies.
Kelun-Biotech’s TROP2 ADC Sacituzumab Tirumotecan Accepted by China’s Center for Drug Evaluation
Kelun-Biotech's TROP2 ADC Sacituzumab Tirumotecan Accepted by China's Center for Drug Evaluation
US FDA Grants Accelerated Approval to Telisotuzumab Vedotin for NSCLC with high c-Met protein...
The US Food and Drug Administration (FDA) has granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis®, AbbVie; Previously known as ABBV-399; See Drug description and ADC Drugmap)*, a c-Met-directed antibody-drug conjugates (ADC) for ther treatment of adults patients diagnosed with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein over-expression who received a prior systemic therapy.
FDA Grants Fast Track Designation ADRX-0706, a Nectin-4 ADC for the Treatment of Advanced...
FDA Grants Fast Track Designation ADRX-0706, a Nectin-4 ADC for the Treatment of Advanced Cervical Cancer
