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FDA approves new adjuvant treatment for patients at high risk of recurrent renal cell carcinoma.

November 18, 2021

KCCure welcomes the U.S. Food and Drug Administration (FDA) decision to approve the use of Merck’s pembrolizumab (Keytruda) for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following surgical resection.

Keytruda is an anti-PD-1 checkpoint inhibitor that helps the immune system detect and fight tumor cells. This is the first approval for an immunotherapy agent in the adjuvant setting and the second FDA approved adjuvant agent in RCC.

Approval was based on results from the KEYNOTE-564 trial. Patients enrolled in the study who received Keytruda following surgery had fewer recurrences (22%) versus patients not receiving adjuvant treatment (30%).

“Immune based adjuvant therapy provides an exciting new option to help prevent recurrent disease for a patient population in desperate need of improved outcomes.” said Dena Battle, President of KCCure.

“We look forward to working with partners in the field to develop effective communication tools to explain the risk and benefits of this new option so that patients can make informed choices.” 

If you or a loved one has been diagnosed with localized or locally advanced kidney cancer, please join our patient community to connect with others. For more information about adjuvant treatment, click here.

KCCure is an evidence based, patient driven advocacy organization, dedicated to improving outcomes for those impacted by kidney cancer through outreach, education and research.



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