Inclusion of data on treatment discontinuation in the Tasigna® product monograph approved by Health Canada for CML patients who achieve a sustained molecular response(i)

• Tasigna^® is the first tyrosine kinase inhibitor (TKI) to receive approval for the inclusion of treatment discontinuation data in its product monographⁱ
  
  
• Approval is based on two studies showing more than half of patients remained in remission after stopping treatmentⁱ
  
  
• Not having to take treatment has the potential to reduce medication-related burdens for patients who achieve a sustained molecular response

DORVAL, QC, Nov. 13, 2018 /CNW/ - Novartis is pleased to announce that Health Canada has approved the inclusion of treatment discontinuation (treatment free remission – TFR) data in the Tasigna^® (nilotinib) Product Monograph. Tasigna^® is the first tyrosine kinase inhibitor (TKI) to include data in the Product Monograph on attempting treatment discontinuation in eligible Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) patients who have achieved a sustained molecular response (MR4.5)ⁱ.

To be eligible for treatment discontinuation, patients must be treated for a minimum of three years and achieve a sustained molecular response (MR4.5) for at least one year. This means that the number of cells containing the genetic abnormality that causes CML is either very small or undetectableⁱⁱ. Patients who meet this criterion can be eligible for TFR, which involves taking no medication but having blood monitoring at regular intervals to ensure their cancer remains in remissioni.

"Advances in the management of CML have helped make it a chronic disease for most people," said Lisa Machado, founder, The Canadian CML Network. "Now, treatment-free remission has added another element of hope, especially for those who struggle with life-affecting side effects. TFR is also changing the conversations that doctors have with patients. We are no longer being told that daily medication will be a permanent part of our lives. Now the conversation is focused on meeting the criteria needed to stop safely in the future, which is in consultation with a doctor and only when regular monitoring is available."

Sustained molecular response achieved by patients over several years on treatment led to studies investigating the ability to maintain response after stopping treatment. The results of two major Novartis studies, ENESTfreedom and ENESTop, formed the basis for the Health Canada approval of the inclusion of the TFR data in the Tasigna^® Product Monographⁱ.

"Novartis has a long history of developing innovative blood cancer treatments. The long-term goal for Novartis in CML over the past 25 years has been to significantly improve survival of CML patients. Now, thanks to clinical research, we can go a step further and allow patients to remain in remission even after stopping their treatment," said Ron Morcos, Franchise Head, Hematology, Novartis Pharmaceuticals Canada Inc. "We are very proud to have achieved this significant goal that provides the option of initiating a treatment that may allow patients to one day be able to live their lives treatment-free."

"The ability to allow patients with CML who have had a sustained molecular response to stop their therapy is a major milestone in the treatment of this form of blood cancer," said Dr. Isabelle Bence-Bruckler, hematologist, and Associate Professor of Medicine at the University of Ottawa. "This can allow some patients to live treatment-free with regular monitoring – a goal we have sought and worked towards for many years."

About CML
CML is a type of cancer in which the body produces cancerous white blood cells.  Almost all patients with CML have an abnormality known as the "Philadelphia chromosome", which produces a protein called Bcr-Abl. Bcr-Abl causes malignant white blood cells to proliferateⁱⁱⁱ. Approximately 500 Canadians are diagnosed with CML each year, usually in middle age or later in life, and 90-95% of cases are caused by the Philadelphia chromosome^iv. According to a case review by a major U.S. cancer centre, before 1983, the eight-year survival rate for chronic phase CML was 15% or less; it rose to 42-65% by 2000^v. Now, a person with CML who is in remission after two years on a TKI has the same life expectancy as someone who doesn't have cancer^vi.

Novartis Commitment to CML
Novartis' ongoing research in Ph+ CML has helped transform the disease from a fatal leukemia to a chronic condition in many patients. The company maintains an unwavering commitment to scientific innovation and access to care for patients worldwide. As an organization committed to patients, Novartis continues to pursue ambitious goals with courage, passion and commitment for the global CML community.

About Novartis Pharmaceuticals Canada
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2017, the company invested $51 million in research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs approximately 750 people in Canada and is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. For further information, please consult www.novartis.ca.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 125,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

Tasigna is a registered trademark.

REFERENCES

__________________________________
ⁱ Novartis Pharmaceuticals Canada Inc., Tasigna^® Product Monograph. July 24, 2018.
ⁱⁱ CML Advocates Network, A patient-friendly summary of the European LeukemiaNet recommendations (2013) for the management of Chronic Myeloid Leukemia, Response definitions, accessed September 2018, at: https://www.cmladvocates.net/education/eln-recommendations/391#responsedefinitions 
ⁱⁱⁱ National Cancer Institute. Chronic Myelogenous Leukemia Treatment (PDQ^®)–Patient Version, accessed September 2018, at: https://www.cancer.gov/types/leukemia/patient/cml-treatment-pdq#section/all 
^iv Canadian CML Network, Understanding CML, accessed September 2018, at: https://cmlnetwork.ca/i-have-cml-now-what/#understandingcml 
^v Kantarjian H et al, Improved survival in chronic myeloid leukemia since the introduction of imatinib therapy: a single-institution historical experience, Blood. 2012 Mar 1; 119(9): 1981–1987, accessed September 2018, at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3311242/ 
^vi National Cancer Institute, How Imatinib Transformed Leukemia Treatment and Cancer Research, accessed September 2018, at: https://www.cancer.gov/research/progress/discovery/gleevec

SOURCE Novartis Pharmaceuticals Canada Inc.

Novartis Media Relations, Daphne Weatherby, Novartis Corporate Communications, [phone], E-mail: [email protected], Spectrum Advisors, [phone], [email protected]

Related Links

http://www.novartis.ca