Guideline Updates

NCCN Updates Clinical Practice Guidelines for CLL/SLL

December 14, 2020

The National Comprehensive Cancer Network (NCCN) recently released an updated version of its clinical practice guideline for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

For patients without del(17p)/TP53 mutations:

  • Relapsed/Refractory Therapy was changed to Second-Line and Subsequent Therapy
  • Frail patients with significant comorbidity and patients aged >65 years without significant comorbidities
    • Zanubrutinib was added as a second-line and subsequent therapy option for patients with intolerance or contraindication to other BTK inhibitors as a category 2A recommendation; other recommended regimen.

For patients with del(17p)/TP53 mutation:

  • Relapsed /Refractory Therapy was changed to Second-Line and Subsequent Therapy
  • Zanubrutinib was added as a first-line therapy option for patients with contraindication to other BTK inhibitors as a category 2A recommendation; other recommended regimen.
  • Zanubrutinib was added as a second-line and subsequent therapy option for patients with intolerance or contraindication to other BTK inhibitors as a category 2A recommendation; other recommended regimen.

Zanubrutinib is an FDA-accelerated approved drug for the treatment of adult patients with mantle cell lymphoma (MCL) who have received ≥1 prior therapy. Zanubrutinib is also listed in the NCCN Guidelines as a Category 2A for second line therapy in MCL.  However, zanubrutinib is not FDA-approved for any other indications at this time, including CLL/SLL.

The NCCN Drugs and Biologics CompendiumTM to the Centers for Medicare & Medicaid services states that “indications that the NCCN Drugs and Biologics CompendiumTM lists as “recommended” will be considered medically accepted indications for the purposes of determining coverage policy.”Janelle Bradley