FDA approval for Venetoclax

The FDA has recently granted approval for Venetoclax for patients with CLL or SLL, with or without 17p deletion, who have received at least one prior therapy. Venetoclax actually is a BCL-2 Inhibitor where the mechanism of action of Venetoclax is as a P-Glycoprotein Inhibitor. The physiologic effect of Venetoclax is by means of Increased Cellular Death.

This approval was based On MURANO trial of venetoclax with rituximab (VEN+R) versus bendamustine with rituximab (B+R) in 389 patients with CLL who had received at least one prior line of therapy. Efficacy was based on progression-free survival (PFS) as assessed by an Independent Review Committee. After a median follow-up of 23 months, the median PFS was not reached in the VEN+R arm and was 18.1 months (95% CI: 15.8, 22.3) in the B+R arm (HR 0.19; 95% CI: 0.13, 0.28; p<0.0001). The overall response rate was 92% in the VEN+R arm compared to 72% for those treated with B+R.

In patients treated with VEN+R, the most common adverse reactions (incidence ≥20%) were neutropenia, diarrhea, upper respiratory tract infection, fatigue, cough, and nausea. Grade 3 or 4 neutropenia developed in 64% of these patients, and grade 4 neutropenia developed in 31%. Serious adverse reactions occurred in 46% of patients. Serious infections developed in 21% of patients, most commonly pneumonia (9%). Due to rapid reduction in tumor volume, tumor lysis syndrome (TLS) is an important identified risk with venetoclax treatment. All approved venetoclax regimens begin with a 5-week ramp-up.

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Source: https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm610308.htm | https://pubchem.ncbi.nlm.nih.gov/compound/abt-199#section=Top