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FDA Approval of Venetoclax in Combination with Rituximab (V+R) for Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Patients Who Have Received One Prior Therapy

This content was current as of the date it was released. In science and medicine, information is constantly changing and may become out-of-date as new data emerge.

This is great news for CLL patients a few good reasons.

  • First it is the first non-chemo combination approved for CLL that is fixed duration. One has the option of stopping after two years on venetoclax.
  • Second it is approved for all relapsed patients, with or without 17p deletion.
  • Third the overall response rate was 92% in the Murano trial that lead to this approval.
  • Finally, the V+R combination reduced the risk of death or disease progression by 81% compared to the bendamustine plus rituximab (BR) combination, admittedly not a strong comparator in a relapsed setting that includes 17p deleted patients.

Having more options, especially highly effective non-chemo fixed duration options, is always a good thing with chronic lymphocytic leukemia.

And there was another underplayed bonus:

The FDA has also approved expansion of the indication of ventoclax as monotherapy for CLL or SLL patients, with or without 17p deletion, who have received one prior therapy. Until now, it had only been approved for patients with 17p deletion.

Nothing comes for free, but there were no new or unexpected toxicities seen with V+R combination.

The main side effects were low blood counts as well as diarrhea.

The concerns with tumor lysis syndrome (TLS) where the venetoclax kills the cancer cells so quickly that the body cannot rid itself of the toxins fast enough were largely mitigated by the mandated slow ramp up in dosing and close monitoring.

Here is a link to the story.

For more on the MURANO trial from ASH 2017 by Dr. George Follows, see this.

For more on venetoclax and how to best take it, please see this written by our pharmacist, Tom Henry. Tom discusses the TLS risk and how it can be nearly eliminated.

These are good times for CLL/SLL patients.

Brian Koffman, MD 6/8/18