CHMP recommends approval of Venclyxto + Gazyvaro in chronic lymphocytic leukemia.- AbbVie

AbbVie announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for Venclyxto (venetoclax) in combination with Gazyvaro (obinutuzumab) for the treatment of patients with chronic lymphocytic leukemia (CLL) who were previously untreated. The positive CHMP opinion is a scientific recommendation for marketing authorization to the European Commission (EC), which is expected to deliver its final decision in the first half of 2020. The CHMP positive opinion is based on results from the Phase III CLL14 clinical trial, which evaluated the efficacy and safety of Venclyxto in combination with obinutuzumab compared with chlorambucil in combination with obinutuzumab. The primary endpoint was progression-free survival (PFS; the time on treatment without disease progression or death) as assessed by an investigator. At the time of analysis, investigator-assessed results demonstrated that patients treated with Venclyxto plus obinutuzumab achieved superior PFS compared to patients treated with obinutuzumab plus chlorambucil. Adverse events were consistent with the known safety profiles of venetoclax and obinutuzumab alone. At least one AE of any grade occurred in 94.3 percent of patients in the venetoclax combination arm, with the most common Grade 3/4 AEs in patients being febrile neutropenia and infections. Tumor lysis syndrome (TLS) was reported in three patients in the venetoclax plus obinutuzumab group (all during treatment with obinutuzumab and before venetoclax). Results from the CLL14 trial were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the New England Journal of Medicine.Comment: In 2018, the EC approved Venclyxto plus rituximab for the treatment of patients with relapsed or refractory (R/R) CLL. Venclyxto monotherapy was previously approved in the EU for R/R CLL in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, and for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.