FDA Updates Nilotinib Label to Include Treatment Discontinuation Recommendations for CML with Sustained Molecular Responses

On December 22, 2017, the U.S. Food and Drug Administration (FDA) updated the product label for nilotinib (Tasigna, Novartis Pharmaceuticals Corp.) to include information on nilotinib discontinuation, post-discontinuation monitoring criteria, and guidance for treatment re-initiation in patients taking nilotinib for Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) who have achieved a sustained molecular response (MR 4.5).

Patients with newly diagnosed Ph+ CML in the chronic phase (CP) and resistant or intolerant Ph+ CML-CP patients who have achieved a sustained molecular response (MR4.5) may be considered for discontinuation after at least three years of nilotinib. To be considered for discontinuation, patients must have typical BCR-ABL transcripts. An FDA-authorized test with a detection limit below at least MR4.5 must be used to determine discontinuation eligibility. Patients must be frequently monitored by this test to detect possible loss of remission.

Common adverse reactions in patients who discontinued nilotinib include musculoskeletal symptoms including body aches, bone pain, and extremity pain. Some patients experienced prolonged musculoskeletal symptoms. The long-term outcomes of patients discontinuing versus continuing treatment are unknown at this time.

Read the FDA announcement.

Posted 1/2/2018