The FDA Briefing Materials For A June 2017 Advisory Committee Meeting On Victoza Include A Discussion Of This Safety Issue
On June 20, 2017 there will be an FDA Advisory Committee meeting to discuss Novo Nordisk's supplemental New Drug Application (sNDA) for approval of Victoza® (liraglutide) injection to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and high cardiovascular risk, given as an adjunct to standard treatment of cardiovascular risk factors.
In more detail, this FDA Advisory Committee will discuss 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.”
In advance of this meeting 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".
Before we get into that material, here are some previous articles which provide background information:
- Pancreatic Cancer As A Side Effect Of Diabetes Drugs Bydureon, Byetta, Januvia, And Victoza
- Byetta / Januvia / Victoza: Update On Possible Association Between These Newer Diabetes Drugs And Pancreatic Cancer As A Side Effect
- Cancer of The Pancreas: Possible Side Effect For Diabetics Who Use Byetta, Januvia, Or Victoza?
- Emerging Drug Safety Issue: Possible Increased Risk Of Pancreatic Cancer With Byetta, Januvia, And Victoza — Little Is Known About Long-Term Effects
- Byetta And Januvia: More Debate About The Possible Increased Risk Of Pancreatitis, Pancreatic Cancer, And Thyroid Cancer
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Now returning to the FDA Briefing Document for this June 2017 Victoza Advisory Committee meeting, from pages 129 - 133, we get this discussion on the pancreatic cancer safety issue:
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 (https://www.ncbi.nlm.nih.gov/pubmed/20981102). This suggests that a direct causal role for 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 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 -- as well as, it would seem, Byetta and Januvia:
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, Januvia, Byetta] and the development of pancreatic cancer.
We will continue to follow this pancreatic cancer safety issue for Victoza, Januvia, and Byetta, watching for any actions taken by the FDA and other drug regulators as well as monitoring the relevant medical journals.
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