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Investegate |F. Hoffmann-La Roche Ltd Announcements | F. Hoffmann-La Roche Ltd: Roche receives FDA approval for first companion diagnostic to identify dMMR solid tumour patients eligible for anti-PD-1 immunotherapy

F. Hoffmann-La Roche Ltd: FDA grants Breakthrough Therapy Designation for Venclexta in combination with azacitidine for the treatment of patients with myelodysplastic syndromes


F. Hoffmann-La Roche Ltd: FDA grants Breakthrough Therapy Designation for Venclexta in combination with azacitidine for the treatment of patients with myelodysplastic syndromes
need for new treatment options
1
Ib
This is the 11th Breakthrough Therapy Designation for Roche s
haematology
Venclexta
demonstrating its potential across multiple blood cancers
Basel, 21 July 2021 - Roche] study is a phase Ib, open-label, non-randomised, multicentre, dose-finding study evaluating Venclexta/Venclyxto (venetoclax) in combination with azacitidine in treatment-naïve patients with higher-risk myelodysplastic syndromes (MDS) comprising a dose-escalation portion and a safety expansion portion. The primary objectives of the study are to assess the safety profile and pharmacokinetics and determine the recommended phase II dose and dosing schedule of Venclexta/Venclyxto in combination with azacitidine. The response criteria specified in the M15-531 study are based ....

United States , Nathalie Meetz , Jon Kaspar Bayard , Karl Mahler , Mabthera Rituxan , Gazyva Gazyvaro , Sabine Borngr , Gerard Tobin , Bruno Eschli , Venclexta Venclyxto , Birgit Masjost , Loren Kalm , Patrick Barth , Karsten Kleine , Kantar Health , Leukemia Lymphoma Society , Drug Administration , International Working Group , Roche Group , International Prognostic Scoring System , Pharmaceuticals Industry , Roche Group Media Relations , American Cancer Society , Breakthrough Therapy Designation , Breakthrough Therapy Designations , World Health Organization Model Lists ,