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
