Experience and a NCCN Recommendation

SUTENT® (sunitinib malate) has more than a decade of experience

SUTENT has been approved for over 14 years.

More than 350,000 patients have been prescribed SUTENT worldwide, across diagnoses; estimate is based on IMS US and global sales and prescription data from February 2006 to December 2018.1

More than 7000 patients with mRCC have been studied in clinical trials (phase 2, phase 3, or expanded access) in which SUTENT was used in either the treatment or control arm.2-16

In the 1st-line treatment of clear-cell advanced RCC, sunitinib malate (SUTENT®) has a category 2A (preferred) National Comprehensive Cancer Network® (NCCN®) recommendation as an option for favorable-risk patients and a category 2A (other) recommendation as an option for poor/intermediate-risk patients.17
NCCN lists sunitinib malate (SUTENT®) as the only preferred therapy (other than clinical trial) for the 1st-line treatment of non-clear-cell advanced RCC (category 2A). Data from expanded-access trials, phase 2 trials, and retrospective analyses support the clinical activity of sunitinib malate.17
Category 2A: The recommendation is based upon lower-level evidence, and there is uniform NCCN consensus that the intervention is appropriate.
Preferred intervention: based on superior efficacy, safety, and evidence; and, when appropriate, affordability.

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  1. Data on file. Pfizer Inc., New York, NY.
  2. Gore ME, Szczylik C, Porta C, et al. Final results from the large sunitinib global expanded-access trial in metastatic renal cell carcinoma. Br J Cancer. 2015;113(1):12-19. 
  3. Motzer RJ, Hutson TE, Cella D, et al. Pazopanib versus sunitinib in metastatic renal-cell carcinoma. N Engl J Med. 2013;369(8):722-731.
  4. Rini BI, Stenzl A, Zdrojowy R, et al. IMA901, a multipeptide cancer vaccine, plus sunitinib versus sunitinib alone, as first-line therapy for advanced or metastatic renal cell carcinoma (IMPRINT): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2016;17(11):1599-1611.
  5. Motzer RJ, Hutson TE, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007;356(2):115-124.
  6. Motzer RJ, Tannir NM, McDermott DF, et al. Nivolumab plus ipilimumab versus sunitinib in advanced renal cell carcinoma. N Engl J Med. 2018;378(14):1277-1290.  
  7. Motzer RJ, Powles T, Atkins MB, et al. IMmotion151: a randomized phase III study of atezolizumab plus bevacizumab vs sunitinib in untreated metastatic renal cell carcinoma (mRCC). J Clin Oncol. 2018;36(6):578.
  8. Escudier B, Porta C, Bono P, et al. Randomized, controlled, double-blind, cross-over trial assessing treatment preferences for pazopanib versus sunitinib in patients with metastatic renal cell carcinoma: PISCES study. J Clin Oncol. 2014;32(14):1412-1418.
  9. Escudier B, Roigas J, Gillessen S, et al. Phase II study of sunitinib administered in a continuous once-daily dosing regimen in patients with cytokine-refractory metastatic renal cell carcinoma. J Clin Oncol. 2009;27(25):4068-4075.
  10. Jonasch E, Slack RS, Geynisman DM, et al. Phase II study of two weeks on, one week off sunitinib scheduling in patients with metastatic renal cell carcinoma. J Clin Oncol. 2018;36(16):1588-1593.
  11. Choueiri TK, Halabi S, Sanford BL, et al. Cabozantinib versus sunitinib as an initial targeted therapy for patients with metastatic renal cell carcinoma of poor or intermediate risk: the Alliance A031203 CABOSUN trial. J Clin Oncol. 2017;35(6):591-597.
  12. Ornstein MC, Wood LS, Elson P, et al. A phase II study of intermittent sunitinib in previously untreated patients with metastatic renal cell carcinoma. J Clin Oncol. 2017;35(6):1764-1769.
  13. Hainsworth JD, Reeves JA, Mace JR, et al. A randomized, open-label phase 2 study of the CXCR4 inhibitor LY2510924 in combination with sunitinib versus sunitinib alone in patients with metastatic renal cell carcinoma (RCC). Target Oncol. 2016;11(5):643-653.
  14. Lee JL, Kim MK, Park I, et al. RandomizEd phase II trial of Sunitinib four weeks on and two weeks off versus Two weeks on and One week off in metastatic clear-cell type REnal cell carcinoma: RESTORE trial. Ann Oncol. 2015;26(11):2300-2305.
  15. Study of the safety and efficacy of SU-011,248 in adult patients with advanced kidney cancer. https://clinicaltrials.gov/ct2/show/NCT00054886. Accessed May 30, 2018.
  16. Uemura H, Shinohara N, Yuasa T, et al. A phase II study of sunitinib in Japanese patients with metastatic renal cell carcinoma: insights into the treatment, efficacy and safety. Jpn J Clin Oncol. 2010;40(3):194-202.
  17. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Kidney Cancer V.1.2021. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed August 22, 2020. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org.