FDA Expands Venclexta Approval for Previously Untreated CLL and SLL

The U.S. Food and Drug Administration (FDA) has recently expanded the approval for Venclexta® (venetoclax). Venclexta is now approved for previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL).¹

Venclexta was previously approved for CLL and SLL in people who had previously received at least one prior therapy.

Approval based on research

This approval was based on results from the phase 3 CLL14 clinical trial of 432 patients with previously untreated CLL with coexisting medical conditions. The patients receiving venetoclax in combination with obinutuzumab had a statistically significant improvement in progression-free survival, which is defined as the length of time during and after treatment that a patient lives with a disease but it does not get worse.¹

How venetoclax works

Venetoclax is an oral B-cell lymphoma-2 (BCL-2) inhibitor. BCL-2 is a protein that is found in large numbers on certain cancer cells and is involved in the cancer cell’s survival and resistance to chemotherapy. Venetoclax binds directly to this protein, weakening and killing cancer cells.²