November 13, 2018

First Quantitative Diagnostic Test Validated for Treatment-free Remission for Eligible Patients with Ph+ CML-CP Treated with Tasigna® Cleared by Health Canada

PORTLAND, OR and CAMBRIDGE, MA – November 13, 2018 – MolecularMD Corporation received regulatory approval from Health Canada for the MRDx® BCR-ABL Test, a quantitative diagnostic test used as an aid to monitor treatment with a Tyrosine Kinase Inhibitor (TKI) in Philadelphia chromosome positive (Ph+) Chronic Myeloid Leukemia (CML) patients and in identifying patients in the chronic phase being treated with Tasigna® (nilotinib) capsules who, after sustaining a deep molecular response of MR4.5, may be candidates  to attempt treatment-free remission (TFR) and for monitoring of TFR. The approval is the first quantitative diagnostic test for TFR in Canada, and follows U.S. Food and Drug Administration (FDA) clearance of the test in late 2017.

TFR is the ability for eligible patients who achieved a sustained MR4.5 to maintain MMR (frontline) or MR4 (second line) after discontinuing Tasigna, a BCR-ABL TKI also approved in Canada1.  These patients no longer take daily oral therapy but continue to be actively managed through frequently scheduled monitoring with the MRDx BCR-ABL Test to identify a loss of molecular responses.

“This is an exciting milestone for the MRDx BCR-ABL Test, enabling it to become more broadly accessible to patients beyond the United States,” said Dan Snyder, CEO of MolecularMD.  “The test ensures that physicians have the information needed to identify Tasigna-treated patients who  meet the stringent eligibility criteria to attempt TFR and provides the robust sensitivity and accuracy necessary for monitoring minimal residual disease with confidence.” Approximately 2,700 Canadians are living with, or are in remission from CML4.

MolecularMD is the exclusive manufacturer of the MRDx BCR-ABL Test and intends to provide  the quantitative diagnostic kit to reference laboratories in Canada that support their clinicians treating Ph+ and CML patients.

®  Tasigna is a registered trademark of Novartis AG.

References:

  1. Tasigna® (nilotinib capsules) Canadian approved Product Monograph dated July 24, 2018
  2. Hochhaus A, Saglio G, Hughes TP, et al. Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial. Leukemia 2016; 30: 1044–1054.
  3. Hochhaus A, Masszi T, Giles FJ, et al. Treatment-free remission following frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the ENESTfreedom study. Leukemia 2017; 31: 1525–1531.
  4. Leukemia and Lymphoma Society, Canada.