Published

May 11, 2025

Lenvatinib with everolimus [LNV1]

The treatment of previously treated advanced renal cell carcinoma

  1. The application has been made by and the first cycle of systemic anti-cancer therapy will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy
  2. The patient has a confirmed histological diagnosis of renal cell carcinoma with a clear cell component Note: papillary, chromophobe and Xp11 translocation sub types can be treated as per clear cell pathway
  3. The patient has either metastatic disease or inoperable locally advanced disease
  4. The patient has previously received only 1 vascular endothelial growth factor (VEGF)-targeted systemic therapy for advanced/metastatic renal cancer*
  5. The patient has progressed on previous treatment or within 6 months of discontinuing previous treatment
  6. The patient has an ECOG performance status of either 0 or 1* *Patients with a performance status of 2 or more are not eligible for lenvatinib with everolimus
  7. The patient has received no previous treatment with either lenvatinib or everolimus
  8. The patient either has no brain metastases or, if the patient has brain metastases, then these have been treated and are symptomatically stable
  9. Lenvatinib with everolimus will be continued until loss of clinical benefit or unacceptable toxicity or patient choice to stop treatment
  10. If unacceptable toxicity occurs, the daily doses of lenvatinib and, if necessary, everolimus are to be modified as needed according to the dose/management plan as set out in section 4.2 of the Summary of Product Characteristics for lenvatinib (Kisplyx)
  11. No treatment breaks of more than 6 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or intercurrent comorbidities to improve) 12.Lenvatinib (Kisplyx) and everolimus are to be otherwise used as set out in their Summaries of Product Characteristics

NHS funded From: 24 April 2018

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CDF Managed Access: NA

NICE Technology Appraisal: TA498 (24 January 2018)

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