The application was reviewed under Oncology Priority Review Program
This is the fourth approval for Venclexta and fifth breakthrough designation
AbbVie has announced that Venclexta in combination with obinutuzumab for the treatment of the chemotherapy-free treatment of Chronic Lymphocytic Leukemia in the first line. The product has received the breakthrough designation and early submission was based on the Real-Time Oncology Review (RTOR) pilot program.
The approval is based on the CLL14 trial in which the combination of Venclexta plus obinutuzumab compared to patients who received chlorambucil plus obinutuzumab.
The patient arm receiving the Venclexta plus obinutuzumab reduced the risk of disease progression by 67% compared with chlorambucil plus obinutuzumab combination.
49% of the patients taking Venclexta plus obinutuzumab showed severe adverse events including febrile neutropenia and pneumonia. The other adverse events reported were neutropenia (60%), diarrhea (28%), fatigue (21%), nausea (19%), anemia (17%), and upper respiratory tract infection (17%).