Shots:

• The approval is based on P-III CLL14 study assessing Venclyxto (venetoclax) + obinutuzumab vs obinutuzumab + chlorambucil in 432 patients with previously untreated CLL and coexisting medical condition
• The P-III CLL14 study results: median follow up @28mos. superior PFS; @40mos. median PFS had not been reached (35.6mos.); @36mos. PFS (81.9% vs 49.5%) @1yr. patients experienced deep response as measured by higher rates of undetectable MRD or CR
• Venclyxto is a first-in-class therapy targeting BCL-2 protein and works to restore the process of apoptosis and has received a CHMP’s positive opinion for MAA in combination with obinutuzumab to treat CLL in Jan’2020

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Ref: AbbVie | Image: abbvie