EU approves Venclyxto + Gazyva for chronic lymphocytic leukemia.- AbbVie

AbbVie announced that the European Commission (EC) has approved Venclyxto (venetoclax) in combination with Gazyva (obinutuzumab) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who were previously untreated. Venclyxto is also approved in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy, and as a monotherapy for the treatment of CLL in the presence or absence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor.This most recent approval is based on results from the Phase III CLL14 clinical trial primary analysis (median follow up of 28 months), which demonstrated superior progression-free survival (PFS; the time on treatment without disease progression or death) as assessed by investigators in patients treated with Venclyxto plus obinutuzumab compared to patients who received a standard of care chemotherapy regimen of chlorambucil plus obinutuzumab (hazard ratio 0.35; 95% CI (0.23,0.53), p<0.0001, medians not yet reached). at an updated cll14 efficacy analysis (median follow-up of 40 months), the median pfs had not been reached in the venclyxto + obinutuzumab arm and was 35.6 months [95% ci: 33.7,40.7] in the obinutuzumab + chlorambucil arm (hazard ratio 0.31; 95% ci: 0.22, 0.44). the 36-month pfs estimate in the venetoclax plus obinutuzumab arm was 81.9% [95% ci: 76.5, 87.3] and in the obinutuzumab plus chlorambucil arm was 49.5% [95% ci: 42.4, 56.6]. additionally, after completing one year of treatment, patients treated with the venclyxto combination experienced deep response as measured by higher rates of undetectable minimal residual disease (mrd) or complete response (cr) as compared to patients receiving a standard of care regimen.in the trial, adverse events (aes) were consistent with the known safety profiles of venetoclax and obinutuzumab alone. at least one ae of any grade occurred in 94.3% of patients in the venetoclax combination arm. the most common grade 3 4 aes were 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).>