FDA approves MRDx BCR-ABL Test as a companion diagnostic to Tasigna in Chronic Myeloid Leukemia Ph+.- MolecularMD.

MolecularMD Corporation announced the FDA authorization of the MRDx BCR-ABL Test as a companion diagnostic. The MRDx Test is indicated as an aid in identifying Philadelphia chromosome positive (Ph+) Chronic Myeloid Leukemia (CML) patients in the chronic phase being treated with Tasigna (nilotinib) capsules who may be candidates for treatment discontinuation and for monitoring of treatment-free remission (TFR).

The TFR data in the Tasigna label approved by the FDA includes the use of the MolecularMD MRDx BCR-ABL Test in the ENESTfreedom and ENESTop clinical studies. These trials evaluated the potential to maintain deep molecular response after stopping Tasigna therapy among eligible patients 18 years of age or older with Ph+ CML-CP. The trials demonstrated that nearly half of the Ph+ CML-CP patients who discontinued Tasigna remained in TFR nearly two years after stopping treatment. Among patients who did lose molecular response during the TFR phase of the trials, nearly all regained MMR when Tasigna therapy was promptly reinitiated.