Novartis: Health Canada approves Rydapt(TM) (midostaurin), first targeted therapy for common form of acute myeloid leukemia (AML) Dienstag, 05. Dezember 2017 - 12:28
- Targeted therapy treats most common gene mutation (FLT3) found in more than one third of AML patients[3]
Dorval, Quebec, December 5, 2017 – Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that Rydapt™ (midostaurin), the first targeted therapy for FLT3 mutated acute myeloid leukemia (AML)[1],[2] has been approved following a priority review by Health Canada.
AML accounts for 24% of all leukemias in Canada. It is the most common acute leukemia in adults and can advance quite rapidly without treatment[4]. Rydapt is approved to be used with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy for the treatment of adult patients with newly diagnosed FLT3-mutated AML[5]. This is the most common gene mutation in AML, found in more than one third (37%) of patients[3]. Health Canada approval of Rydapt is based on the pivotal phase III study (RATIFY) which investigated the efficacy and safety of Rydapt in combination with standard chemotherapy versus placebo plus standard chemotherapy[5].
“We are very pleased to bring the first targeted therapy to AML patients with the FLT3 mutation. There has been a long gap in development of innovative therapies for this serious blood cancer and this advance represents new hope for these patients,” said Winselow Tucker, General Manager of Oncology Business Unit of Novartis Pharmaceuticals Canada Inc. “The arrival of Rydapt in Canada is a result of our commitment to developing important new therapies for Canadians with blood and other types of cancers.”
“AML is a very serious and life-threatening condition, and this is the first time in a long time that we’ve seen an advance in this area and it’s encouraging for me as a treating physician,” said Dr. Aaron Schimmer, medical oncologist and senior scientist, Princess Margaret Cancer Centre, University Health Network and investigator for the RATIFY trial. “This represents a step forward in the way that we treat newly diagnosed AML patients with the most common gene mutation.”
About acute myeloid leukemia (AML)
Leukemia refers to cancer of the blood cells and exists in different forms. Acute forms of leukemia can advance quite rapidly without treatment; “chronic” forms progress much more slowly. “Myeloid” leukemia involves cancer in the myeloid stem cells responsible for developing new blood cells. More than 22,000 Canadians are living with or in remission from all types of leukemia, almost 60% of them men. An estimated 5,900 Canadians were diagnosed with all types of leukemia in 2016 and 2,900 died from it. AML, accounting for 24% all leukemia in Canada, is the most common acute form of the disease and second most common overall. The median age for diagnosis of AML is 67. The age-standardized five-year survival rate for leukemia in Canada is 58% for males and 59% for females, much lower than rates for other types of cancer such as thyroid (95%), prostate (81%), melanoma (79%) and breast (80%)[4].
About Rydapt
Rydapt (midostaurin) is indicated in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy for the treatment of adult patients with newly diagnosed FLT3-mutated acute myeloid leukemia (AML). A validated test is required to confirm the FLT3 mutation status of AML[5].
Novartis Commitment to Oncology
At Novartis, our mission is to discover new ways to help improve and extend people’s lives. We use science-based innovation to address some of society’s most challenging healthcare issues. We discover and develop innovative treatments and find new ways to deliver them to as many people as possible. We strive to change the practice of medicine. We aspire to approach things differently - to make discoveries that take medicine in new directions. We look to tomorrow to inspire us today. Never satisfied with the status quo, we imagine what’s next.
As one of the leading pharmaceutical companies in oncology, Novartis globally offers a portfolio of more than 20 approved therapies and approximately 30 compounds in development. We are passionate about what we do and the impact we have on patients and societies. We are Novartis, and we are reimagining medicine.
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 2016, the company invested $48.8 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 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 119,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.
-30-
Novartis Media Relations
Daphne Weatherby
Novartis Oncology Communications
+1 514 633 7873
E-mail: camlph.communications@novartis.com
Spectrum Advisors
+1 514 234 4095
mediarelations@spectrumadvisors.ca
Rydapt is a trademark.
References
[1] Schiller GJ. High-risk acute myelogenous leukemia: treatment today ... and tomorrow. Hematology Am Soc Hematol Educ Program. 2013; 2013:201-208.
[2] Lin TL, Levy MY. Acute myeloid leukemia: focus on novel therapeutic strategies. Clin Med Insights Oncol. 2012; 6:205-217
[3] Patel JP, Gönen M, Figueroa ME et al. Prognostic relevance of integrated genetic profiling in acute myeloid leukemia. N Engl J Med. 2012;366(12):1079-1089, p. 1082
[4] Leukemia and Lymphoma Society of Canada, Blood Cancer in Canada Facts and Stats 2016, p. 5-7, accessed September 29, 2017 at: http://www.llscanada.org/sites/default/files/National/CANADA/Pdf/InfoBooklets/Blood_Cancer_in_Canada_Facts_%26_Stats_2016.pdf
[5] Novartis Pharmaceuticals Canada Inc. Rydapt™ Product Monograph. P. 3, 23 July 21, 2017.