Conquering CML The Breakthrough Paradigm Change of Treatment-free Remission - 15

Conquering CML | The Breakthrough Paradigm Change of Treatment-free Remission

MRDx BCR-ABL Test Supports
Tasigna® Label Update
®

I

n late December, in what marked a significant breakthrough for patients with
Philadelphia chromosome positive
Ph+ Chronic Myeloid Leukemia (CML), the
U.S. Food and Drug Administration (FDA)
updated the label for the Novartis cancer drug Tasigna® (nilotinib) that included
information for physicians about how
to discontinue use of the drug in certain
patients with Ph+ CML.
The label update contains information on
treatment-free remission (TFR) data that
makes Tasigna® the first-and to date,
only-second generation tyrosine kinase
inhibitor (TKI) whose patients may attempt
to discontinue taking the drug based on

15

A Clinical OMICs eBook

generated with the
MRDx® BCR-ABL Test from MolecularMD.

their response to treatment. The TFR label
update was supported by two separate clinical studies, ENESTfreedom and ENESTop.
Minimal residual disease (MRD) and molecular response (MR) data for the trials were

TFR is defined as the ability of patients to
sustain major molecular response (MMR) or
deep molecular response (DMR) after discontinuing use of the drug. The two clinical
studies evaluated patients over the age of
18 with Ph+ CML in the chronic phase and
their potential to maintain DMR. Of these
patients, 49% who discontinued Tasigna®
remained in TFR for two years. Of the
patients who lost TFR, 98% regained DMR
when they began taking the drug again.
In the FDA's announcement of the label
change, Richard Pazdur, M.D., Director of
www.clinicalomics.com

http://www.clinicalomics.com

Conquering CML The Breakthrough Paradigm Change of Treatment-free Remission

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