F Hoffmann-La Roche Ltd: Roche receives positive CHMP opinion for Gavreto (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer
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F Hoffmann-La Roche Ltd: Roche opens access to pathology imaging tools to improve patient care
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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 on the modified Internatio