KEYTRUDA in advanced Renal Cell Carcinoma (aRCC)
KEYTRUDA® (pembrolizumab) Prescribing Information for Great Britain & Northern Ireland [External links]
KISPLYX® (lenvatinib) Prescribing information for Great Britain & Northern Ireland [External link]
KEYTRUDA is indicated for:
- KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of advanced renal cell carcinoma (aRCC) in adults.1,2
- KEYTRUDA is indicated in combination with axitinib for the first-line treatment of advanced renal cell carcinoma (aRCC) in adults.1
Please consult the SmPC for further information before making any prescribing decisions.
KEYTRUDA reimbursement for 1L aRCC in the UK
KEYTRUDA and KISPLYX® (lenvatinib) reimbursement in the UK
NICE recommends pembrolizumab* with lenvatinib as an option for untreated advanced renal cell carcinoma in adults, only if:3
- their disease is intermediate or poor risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria, and
- nivolumab with ipilimumab would otherwise be offered
SMC accepts restricted* use of pembrolizumab in combination with lenvatinib for adults with advanced RCC, as 1L treatment.4
*SMC and NICE restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.4
KEYTRUDA and axitinib reimbursement in the UK
SMC accepts restricted* use of pembrolizumab in combination with axitinib, for the first-line treatment of advanced renal cell carcinoma in adults.5
*SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.5
Abbreviations
1L: first-line; NICE: National Institute for Health and Care Excellence; RCC: renal cell carcinoma; SMC: Scottish Medicines Consortium.
References
- KEYTRUDA (pembrolizumab) Summary of Product Characteristics.
- KISPLYX (lenvatinib) Summary of Product Characteristics.
- NICE Lenvatinib with pembrolizumab for untreated advanced renal cell carcinoma. Available at https://www.nice.org.uk/guidance/ta858/chapter/1-Recommendations.
- SMC Lenvatinib (KISPLYX). Available at https://www.scottishmedicines.org.uk/medicines-advice/lenvatinib-kisplyx-abb-smc2476/.
- SMC Pembrolizumab. Available at https://www.scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-full-smc2247/.
Supporting documentation
KEYTRUDA Prescribing Information for Great Britain & Northern Ireland
KISPLYX Prescribing information for Great Britain & Northern Ireland
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