The European Commission has granted approval to United States-based AbbVie and Switzerland-based Roche for the combination of Venclyxto (venetoclax) and MabThera (rituximab) intended to treat relapsed/refractory chronic lymphocytic leukaemia in adult patients who had received at least one prior therapy, it was reported on Friday.
Venclyxto, which selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein, is being developed by AbbVie and Roche. MabThera, which is owned by Roche, is a monoclonal antibody that target cells having the CD20 marker on their surface.
The approval will enable more patients to be treated with Venclyxto in the second-line setting while giving healthcare providers the ability to prescribe the drug to a larger population of relapsed/refractory chronic lymphocytic leukaemia patients compared to the earlier approved indication of the drug as a monotherapy in the European Union. The approval of the combination includes 28 member states of the EU, along with Iceland, Liechtenstein and Norway. The product has received approval as a result of a positive opinion adopted by the European Committee for Medicinal Products for Human Use (CHMP) in September 2018 for the marketing authorisation application of the combination therapy for the intended indication, supported by the data from the MURANO phase 3 trial.
AbbVie's ELAHERE receives full US FDA approval
Johnson & Johnson's OPSYNVI receives US FDA approval
Outlook Therapeutics receives positive CHMP opinion for ONS-5010 in wet AMD treatment
Human Immunology Biosciences receives ODD from FDA for felzartamab
Eton Pharmaceuticals acquires PKU GOLIKE, expanding rare disease portfolio
Vertex receives FDA clearance for VX-407 Investigational New Drug Application for ADPKD
Phanes Therapeutics receives FDA Fast Track designation for PT886
Bio-Thera Solutions signs new licensing agreement with SteinCares
FDA accepts resubmission of Citius Pharmaceuticals, Inc's BLA for LYMPHIR
GSK Plc reports positive Phase III Jemperli data for endometrial cancer
ImmVira receives FDA Fast Track designation for MVR-T3011 IT