Novartis drug Tasigna® is approved by FDA as first and only CML therapy with Treatment-free Remission data in its label

The inclusion of untreated referral data (TFR) provides an additional and novel option in the administration of Ph + CML-CP

The deep and sustained molecular response is included as a key criterion of eligibility to try TFR after treatment with Tasigna.

Approval granted under priority review and based on Novartis trials that evaluate TFR with Tasigna in the first and second line configurations.

Novartis recently stated that the United States Food and Drug Administration (FDA) approved the inclusion of untreated remission data (TFR) on the US product label Tasigna® (nilotinib).

Tasigna is now the first and only BCR-ABL tyrosine kinase inhibitor (TKI) that includes data on attempts to discontinue treatment in eligible adult patients with chronic myeloid leukemia positive for the Philadelphia chromosome in the chronic phase (Ph + CML-CP ) after achieving a response of MR4.5 (BCR-ABL1 International Scale IS u003c = 0.0032%) on your prescription information approved by the FDA.

TFR is the ability to maintain a sustained molecular response * after stopping therapy with TKI in patients with Ph + CML-CP. The TFT requires a planned monitoring of the levels of BCR-ABL1 to identify the possible loss of molecular response.

Our ambition at Novartis has long been to make it possible for some people with CML to stop therapy, said Bruno Strigini, CEO of Novartis Oncology.

We are proud that Tasigna is now the first and only TKI with TFR data on its labeling in the US. UU and in several countries of the world.

This achievement would not have been possible without the association of patients from around the world who participated in our innovative TFR trials, helping Novartis to reimagine what is possible for people living with CML.

With this tag update, Tasigna is the only TKI that provides defined and approved criteria to try and monitor TFR.

This approval follows a priority review for a new Supplemental Drug Application (sNDA) for Tasigna that seeks to aggregate TGF information and is based on the safety and efficacy results of the 96-week analysis of two open-label trials, ENESTfreedom and ENESTop.

These trials evaluated the potential to maintain the maternal mortality rate (BCR-ABL1 = 0.1%) after stopping treatment with Tasigna in eligible adult patients with Ph + CML-CP. The patients in the trials had achieved a MR4.5 sustained with Tasigna in both the first-line fit and after switching from Gleevec® (imatinib mesylate) ** 1.

The trials showed that almost half of the patients with Ph + CML-CP who discontinued Tasigna remained in the TGF approximately two years after stopping treatment.

Among patients who lost the molecular response during the TFR phase of the trials, almost all of them recovered MSY when treatment with Tasigna was quickly restarted1.

The safety data are consistent with previously published studies and the known safety profile of Tasigna1.

TFR data on the Tasigna label approved by the FDA included the use of the MolecularMD MRDx BCR-ABL test, an FDA-authorized diagnostic supplement validated to measure BCR-ABL transcription levels up to MR4.51 .

The interruption of Tasigna should only be attempted under the close supervision of a physician. Frequent monitoring of the patient is required after the Tasigna interruption, so that the possible loss of MMR and MR4.0 (BCR-ABL1 IS u003c = 0.01%) is quickly identified and immediately start the restart of treatment1.

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