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NICE recommends Votrient®▼ (pazopanib) for the first-line treatment of advanced renal cell carcinoma (RCC)

Posted: 4 January 2011 | | No comments yet

Targeted oral treatment slows down the progression of advanced kidney cancer…

Targeted oral treatment slows down the progression of advanced kidney cancer...

Patients in England and Wales living with advanced kidney cancer (renal cell carcinoma – RCC) are one step closer to being able to access Votrient® (pazopanib), a targeted oral treatment, on the National Health Service (NHS). The National Institute for Health and Clinical Excellence (NICE) has issued the Final Appraisal Determination (FAD) recommending Votrient as a first-line treatment option for people with advanced RCC who have not previously received cytokine therapy and who are of Eastern Cooperative Oncology Group (ECOG) performance status 0-1, on the basis that GSK provides the agreed patient access scheme. The access scheme offers a straight discount and makes provision for a possible partial rebate to the NHS in the future, conditional upon the outcome of a head-to-head trial with current standard of care treatment.1

The introduction of targeted cancer therapies has transformed the management of advanced RCC.2-4 However, despite improvements in efficacy, side effects observed with available treatments to date can affect patients’ quality of life and their ability to carry out normal daily activities.5-10 This was acknowledged by the NICE Appraisal Committee in their evaluation of evidence from the patient experts and clinicians. With only one targeted treatment option (sunitinib) recommended by NICE as a first-line treatment until now,11 the NICE recommendation of Votrient will offer patients and clinicians a choice of effective treatment options with different side-effect profiles.

Votrient has been shown to effectively slow down the progression of advanced RCC whilst maintaining QoL compared with placebo; a significant consideration for patients at an advanced stage of disease.12,13 Votrient has an acceptable and manageable toxicity profile. The most frequent adverse events related to Votrient treatment were diarrhoea, hair colour change, hypertension, nausea, anorexia and increased liver enzymes.1

Professor Robert Hawkins, Consultant Medical Oncologist at The Christie, Manchester commented on the NICE decision. Professor Robert Hawkins, Consultant Medical Oncologist at The Christie, Manchester commented on the NICE decision. “We have had a major role in the trials of pazopanib and I welcome its approval by NICE for the treatment of patients with kidney cancer. This is a significant development for advanced kidney cancer patients living in England and Wales as it gives access to a further oral drug with a different side effect profile from that of other licensed agents. With pazopanib, patients have a chance to control their kidney cancer whilst maintaining quality-of-life and avoiding some of the side effects, which can be severe, that can occur with current treatments. The importance of today’s decision, both from the point of view of patients and those treating them, should not be under-estimated.”

Advanced RCC is an aggressive form of kidney cancer with a poor prognosis, due in part to its resistance to chemotherapy, radiotherapy and hormone therapy.14,15 Over 8,000 people in the UK are diagnosed with kidney cancer each year16 and around one third show signs of advanced RCC at the time of diagnosis.2,17,18

Simon Jose, General Manager, GlaxoSmithKline (GSK) UK commented: “NICE has acted quickly in recognising Votrient as a clinical and cost-effective treatment option for advanced kidney cancer. It is UK/PAZ/0148/10 Date of preparation: December 2010 2 often difficult to demonstrate the full value of innovative cancer medicines initially, as the evidence driving that value typically evolves over time as further studies are completed. We recognise this challenge and that is why we have offered an innovative potential future value rebate scheme. We are confident that the ongoing head-to-head study will confirm the full value of Votrient in this setting, but, if not, we will pay a partial rebate to the NHS. This is great news for patients and physicians who can have rapid and equitable access to this treatment, good for the NHS as it delivers value for money and also allows GSK to achieve a fair return for its innovation.”

References

  1. NICE. Pazopanib for the treatment of patients with advanced renal cell carcinoma. Final Appraisal Determination document. [insert URL when available] Accessed December 2010
  2. Motzer RJ, Hutson TE, Tomczak P et al. Sunitinib versus Interferon Alfa in Metastatic Renal- Cell Carcinoma. NEJM. 2007; 356: 115-124
  3. Escudier B, Pluzanska A, Koralewski P et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet. 2007; 370: 2103 – 2111
  4. Hudes G, Carducci M, Tomczak P et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 2007; 356: 2271–2281
  5. Hutson TE, Figlin RA, Kuhn JG et al. Targeted therapies for metastatic renal cell carcinoma: an overview of toxicity and dosing strategies. Oncologist 2008; 13: 1084-1096 UK/PAZ/0148/10 Date of preparation: December 2010 4
  6. Porta C, Szczylik C. Tolerability of first-line therapy for metastatic renal cell carcinoma. Cancer Treat Rev 2009; 35:297–307
  7. Shepard DR, Garcia JA. Toxicity associated with the long-term use of targeted therapies in patients with advanced renal cell carcinoma. Expert Rev Anticancer Ther 2009; 9 (6): 795-805
  8. Pyle L, Beirne D, Bird J et al. Managing the adverse events of sunitinib: a guide to empowering the patients. Cancer Nursing Practice 2008; 7: 42-46
  9. Bird J, Hayter M. A review of the literature on the impact of renal cancer therapy on quality of life. J Clin Nurs 2009; 18: 2783-2800
  10. Schwandt A, Wood LS, Rini B et al. Management of side effects associated with sunitinib therapy for patients with renal cell carcinoma. OncoTargets and Therapy 2009; 2: 51-61
  11. NICE. Sunitinib for the first-line treatment of advanced and/or metastatic renal cell carcinoma. NICE technology appraisal guidance 169. March 2009. http://www.nice.org.uk/nicemedia/live/12143/43556/43556.pdf Accessed December 2010
  12. Sternberg CN, Davis ID, Mardiak J et al. Pazopanib in locally advanced and/or metastatic renal cell carcinoma: results of a randomized Phase III trial. J Clin Oncol 2010 [Epub ahead of print]
  13. Hawkins R, Hodge R, Chen M et al. Quality of Life (QOL) in treatment-naive and cytokine pretreated patients with advanced renal cell carcinoma (RCC) treated with pazopanib: results from a Phase III double-blind, placebo-controlled trial. 2009 ECCO-ESMO Poster Number 132.
  14. Ljungberg B, Hanbury D, Kuczyk M et al. Renal Cell Carcinoma Guideline. 2007; 51: 1502 – 1510
  15. Gupta K et al. Epidemiologic and socioeconomic burden of metastatic renal cell carcinoma (mRCC): a literature review. Cancer Treat Rev 2008; 34: 193-205
  16. Cancer Research UK: Kidney cancer statistics UK. Available at: http://info.cancerresearchuk.org/cancerstats/types/kidney/ Accessed December 2010
  17. Lam JS, Leppert JT, Belldegrum AS et al. Novel treatment approaches in the therapy of metastatic renal cell carcinoma. World J Urol 2005; 23: 202-212
  18. Oudard S, George D, Medioni J et al. Treatment options in renal cell carcinoma: past, present and future. Ann Oncol 2007; 18 (suppl 10): x25-x31