BEERSE,
Outcomes for patients with CLL have improved in the last decade with the advent of oral therapies that target the underlying disease biology.[1] This provides the opportunity to combine these novel treatments for an effective and convenient approach that results in deep responses with time-limited therapy.[1] If approved, I+V will be the first all-oral, once daily, fixed-duration combination treatment with a Bruton's tyrosine kinase (BTK) inhibitor for first-line treatment of patients with CLL.
'With this innovative treatment regimen, healthcare professionals would have the flexibility to use ibrutinib either in a fixed-duration combination or as a continuous therapy, helping them to better tailor frontline CLL therapy based on patients' individual needs,' said
The CHMP positive opinion is supported by data from the pivotal Phase 3 GLOW study (NCT03462719), which demonstrated that I+V was superior to chlorambucil-obinutuzumab with respect to the primary endpoint, progression-free survival (PFS), in elderly or unfit patients with CLL (PFS hazard ratio [HR]: 0.216; 95 percent confidence interval [CI], 0.131 to 0.357; P
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