Positive CHMP opinion for Cabometyx™ (cabozantinib)

Ipsen and its partner Exelixis receive positive CHMP opinion for Cabometyx™ (cabozantinib) for the treatment of advanced renal cell carcinoma in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.
Cabometyx™ (cabozantinib) is the first and only multi-kinase inhibitor with established clinical benefits demonstrated for all three key efficacy endpoints: overall survival (OS), progression-free survival (PFS) and objective response rate (ORR).

July, 22 2016. The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA) provided a positive opinion for Cabometyx™ (cabozantinib) 20, 40, 60mg for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy and recommended it for marketing authorization.

Accelerated review procedure

The positive CHMP opinion was adopted following an accelerated review procedure reserved for medicinal products expected to be of major public health interest. The recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway and Iceland, with a decision expected two months post CHMP opinion.

Approx. 84,400 new cases in Europe in 2012

Renal cell carcinoma (RCC) represents 2-3% of all cancers1, with the highest incidence occurring in Western countries. Generally, during the last two decades until recently, there has been an annual increase of about 2% in incidence both worldwide and in Europe, though in Denmark and Sweden a continuing decrease has been observed2. In 2012, there were approximately 84,400 new cases of RCC and 34,700 kidney cancer related deaths within the European Union3. In Europe, overall mortality rates for RCC have increased up until the early 1990s, with rates generally stabilizing or declining thereafter. There has been a decrease in mortality since the 1980s in Scandinavian countries and since the early 1990s in France, Germany, Austria, the Netherlands, and Italy. However, in some European countries (Croatia, Estonia, Greece, Ireland, Slovakia), mortality rates still show an upward trend with increasing rates4.

Unprecedented clinical results

David Meek, Chief Executive Officer of Ipsen, said:

We are pleased that European patients with renal cell cancer may soon have access to Cabometyx™. Ipsen is very proud to receive this positive CHMP opinion for Cabometyx™, a new drug with unprecedented clinical results in the treatment of advanced renal cell carcinoma. Cabometyx™ has demonstrated robust and consistent benefits regardless of prior treatment, location and extent of tumor metastases in previously treated patients suffering from advanced renal cell carcinoma.

The detailed recommendations for the use of this product will be described in the Summary of Product Characteristics (SmPC), to be made available if the medication receives marketing authorization from the European Commission.

For more information on the METEOR Phase 3 Pivotal study, click here

1 European Network of Cancer Registries. Eurocim version 4.0. European incidence database V2.3, 730 entity dictionary (2001), Lyon, 2001
2 Lindblad P. Epidemiology of renal cell carcinoma. Scand J Surg 2004; 93(2): 88-96 http://www.ncbi.nlm.nih.gov/pubmed/15285559
3 Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, et al. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer 2013 Apr; 49(6): 1374-403. http://www.ncbi.nlm.nih.gov/pubmed/23485231
4 Levi F, Ferlay J, Galeone C, et al. The changing pattern of kidney cancer incidence and mortality in Europe. BJU Int 2008 Apr; 101(8): 949-58 http://www.ncbi.nlm.nih.gov/pubmed/18241251

Updated on 25 July 2016