Venclyxto(venetoclax)

Venclyxto (venetoclax) is indicated for the treatment of chronic lymphocytic leukemia (CLL). It received orphan medicinal product designation on 06 December 2012, and a positive opinion from the CHMP on 13 October 2016. The median age of CLL diagnosis is 72 years, with an incidence rate of 6.2 per 100,000 person-years.

In patients with 17p deletion or TP53 mutation CLL, the median overall survival ranged from 2 to 5 years. For first-line 17p deletion patients, median progression-free survival was 14 months, while in relapsed/refractory 17p deletion patients, it was 6 to 7 months. The overall response rate (IRC assessed) was 79.4%, with a complete response rate (IRC assessed) of 7.5%. For comparison, objective remission rates for ibrutinib were 48% to 65% (IRC assessed) and 83% to 86% (investigator assessed), and for idelalisib/rituximab, it was 85% (IRC assessed). Imbruvica (ibrutinib) and Zydelig (idelalisib) were approved in 2014.

Common adverse events in CLL/SLL subjects included diarrhea (49.1%), nausea (47.4%), and neutropenia (44.8%). Tumor lysis syndrome (TLS) leading to interruption occurred in 2.5% of patients. Concomitant administration with rifampin resulted in a 42% decrease in venetoclax Cmax and a 71% decrease in AUC∞.