Information from Health Canada issued October 14, 2008 about the recently approval of nilotinib (Tasugna)
On September 9, 2008, Health Canada issued a Notice of Compliance under the Notice of Compliance with Conditions (NOC/c) Policy to Novartis Pharmaceuticals Canada Inc. for the drug product Tasigna*. The product was authorized under the NOC/c Policy on the basis of the promising nature of the clinical evidence, and the need for further follow-up to confirm the clinical benefit. Patients should be advised of the fact that the market authorization was issued with conditions.
Tasigna* contains the medicinal ingredient nilotinib (as nilotinib hydrochloride monohydrate) which is a protein-tyrosine kinase inhibitor.
Tasigna* is indicated for the treatment of accelerated phase (AP) Philadelphia chromosome-positive chronic myeloid leukemia (CML) in adult patients resistant to or intolerant of at least one prior therapy including imatinib.
Tasigna* is a potent inhibitor of the Abl tyrosine kinase activity of the Bcr-Abl oncoprotein both in cell lines and in primary Philadelphia chromosome-positive leukemia cells. As a result, Tasigna* selectively inhibits the proliferation and induces apoptosis in primary Philadelphia-chromosome-positive leukemia cells from CML patients.
The market authorization was based on submitted data from quality (chemistry and manufacturing), non-clinical, and clinical studies. The clinical efficacy and safety data submitted consisted of the Phase II component of an ongoing open-label multicentre study. In the interim analysis, 28% of CML-AP patients treated with Tasigna* (n=105) achieved the primary efficacy endpoint of overall confirmed hematologic response, defined as either a complete hematologic response, or no evidence of leukemia. The majority of Tasigna* treated patients experienced adverse reactions at some time. Most reactions were mild to moderate. Discontinuation for adverse events regardless of causality was observed in 14% of CML-AP patients. Further follow-up is needed to confirm the clinical effectiveness of Tasigna*.
Tasigna* 200 mg nilotinib (as nilotinib hydrochloride monohydrate) is presented as capsules. The recommended dose of Tasigna* is 400 mg twice daily. Dosing recommendations are available in the approved Product Monograph.
Tasigna* is contraindicated for patients with long QT syndrome, and patients with known hypersensitivity to nilotinib or to any of the excipients. Tasigna* should be administered under the conditions stated in the approved Product Monograph taking into consideration the potential risks associated with the administration of this drug product (myelosuppression, QT-interval prolongation, hepatotoxicity, sudden deaths, drug-drug and drug-food interactions). Detailed conditions for the use of Tasigna* are described in the approved Product Monograph.
Based on the Health Canada review of data on quality, safety, and effectiveness, Health Canada considers that the benefit/risk profile of Tasigna* is favourable for the treatment of accelerated phase Philadelphia chromosome-positive chronic myeloid leukemia in adult patients resistant to or intolerant of at least one prior therapy including imatinib.