United States-based Johnson & Johnson's Darzalex (daratumumab), in combination with lenalidomide and dexamethasone, has significantly decreased the risk of disease progression in a multiple myeloma study, it was reported yesterday.
The phase three MAIA study indicated that the daratumumab combination decreased the risk of disease progression or death in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The product is a first-in-class biologic targeting CD38, a surface protein that is eminently expressed across multiple myeloma cells, irrespective of disease stage. It is supposed to induce tumour cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity and antibody-dependent cellular phagocytosis. In addition, daratumumab is being studied in a comprehensive clinical development program across different treatment settings in multiple myeloma.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA