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FDA Concern About Whether Victoza Is Associated With Pancreatic Cancer

In advance of the June 20, 2017 FDA Advisory Committee meeting to discuss Novo Nordisk’s supplemental New Drug Application (sNDA) for approval of Victoza® (liraglutide) injection, we reviewed the FDA Briefing Document for this Endocrinologic and Metabolic Drugs Advisory Committee Meeting (EMDAC), which includes a section titled “ONCOLOGY CONSULT: PANCREATIC CANCER”.

In that FDA Briefing Document the results of the so-called LEADER trial: “Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results – A long-term, multi-center, international, randomized double-blind, placebo-controlled trial to determine liraglutide effects on cardiovascular events.” are discussed.

As regards the Victoza – pancreatic cancer safety issue, there is this discussion:

Pancreatic adenocarcinoma is an aggressive malignancy with a high mortality rate. It is most commonly diagnosed at an advanced stage; only 30% of patients are eligible to undergo resection with curative intent. Despite the advanced presentation at diagnosis and aggressive clinical course typically observed in patients with pancreatic cancer, quantitative analysis of the timing of genetic evolution suggests that at least a decade takes place between the initial mutation and development of the first malignant (nonmetastatic) pancreatic cancer cell and that approximately 5 additional years are required for the primary tumor to develop metastatic potential…. This suggests that a direct causal role for [Victoza (liraglutide)] in the initial development of pancreatic cancer in patients participating in the LEADER trial is unlikely given the short latency period between exposure and diagnosis of pancreatic cancer. There is insufficient information available to elucidate whether [Victoza (liraglutide)] treatment plays a role in accelerating the evolution of primary or metastatic disease following occurrence of the initial mutation that will ultimately lead to clinically evident pancreatic cancer, given the relative short follow-up period (median follow-up of 3.5 years).

This part of the document goes on to indicate that the FDA is still concerned about pancreatic cancer being a possible side effect of Victoza:

In summary, taking into consideration the totality of information available, the additional information provided in LEADER does not appear to substantively alter the original FDA and EMA conclusions regarding the lack of sufficient information to conclusively determine whether long term exposure to GLP-RAs increase the risk of pancreatic cancer. Longer follow-up (e.g., 10 years) is recommended to further characterize the relationship between GLP-1 RAs [e.g., Victoza] and the development of pancreatic cancer.

We will continue to follow this pancreatic cancer safety issue for Victoza, watching for any actions taken by the FDA and other drug regulators as well as monitoring the relevant medical journals.

[Read this article in full at original source]


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