Ipsen has announced that the CHMP has provided a positive opinion for Cabometyx™ (cabozantinib) for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.
This was based on a multinational pivotal Phase III study including sites in the UK.
In addition, the UK’s Medicines and Healthcare Regulatory Agency (MHRA) has granted the treatment a Promising Innovation in Medicine (PIM) designation, indicating a commitment to increase early patient access to this treatment in the area of advanced RCC, which has a high unmet need.
Ewan McDowall, Vice President Commercial Operations, Ipsen UK & Ireland said “We are proud that this significant announcement from the CHMP moves us one step closer to gaining marketing authorisation for cabozantinib in the UK. Its new status as a Promising Innovative Medicine also shows an exceptional commitment from the UK government to ensure patients have access to this new therapy. Advanced renal-cell carcinoma is a condition with a limited number of treatment options and a poor prognosis. However, cabozantinib has unprecedented clinical results and is the first and only investigational monotherapy to demonstrate prolonged survival, progression free survival and high response rates compared to standard of care therapy in patients with advanced renal cell carcinoma (RCC) who have failed previous treatment.”1–5
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.
- Motzer R, Escudier B, McDermott D, et al. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. The New England Journal of Medicine 2015;373(19): 1803-1813
- Rini B, Escudier B, Tomczak P, et al. Comparative eff ectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. The Lancet 2011;378: 1931- 1939
- Motzer R, Escudier B, Oudard S, et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. The Lancet 2008;372: 449 – 456
- Powles T, Staehler M, Ljungberg B, et al. Updated EAU Guidelines for Clear Cell Renal Cancer Patients who Fail VEGF Targeted Therapy. European Urology 2016;69: 4-6
- Choueiri T, Powles T, Escudier B, et al. Overall survival (OS) in METEOR, a randomized phase 3 trial of cabozantinib (Cabo) versus everolimus (Eve) in patients (pts) with advanced renal cell carcinoma (RCC). Abstract 4506 presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2016 in Chicago, IL.