Share This Post



Washington, DC, ——– – The Kidney Cancer Research Alliance (KCCure) welcomes the U.S. Food and Drug Administration (FDA) decision to approve pembrolizumab (KEYTRUDA) in combination with axitinib (INLYTA) as first-line treatment for patients with advanced renal cell carcinoma (RCC).  

Pembrolizumab is an anti-PD-1 checkpoint inhibitor that helps the immune system detect and fight tumors cells. Axitinib is an anti-angiogenic targeted therapy that inhibits the growth of tumors. This is the first approval of an immunotherapy agent used in combination with a targeted therapy for the treatment of advanced kidney cancer. Axitinib as monotherapy is already approved for patients who have progressed on one line of therapy.

The decision by the FDA was based on the results from the KEYNOTE-426 trial, which investigated the combination of pembrolizumab and axitinib in comparison to sunitinib (SUTENT) in previously untreated metastatic kidney cancer patients. Patients in the combination arm experienced prolonged overall survival compared to patients in the control arm.  

“What’s exciting about this combination is that it shows an overall survival benefit for patients, regardless of their risk status,” said Dr. Hans Hammers, medical oncologist at UT Southwestern Medical Center and KCCure co-founder.  “Pembrolizumab in combination with axitinib is an important new treatment option for providers to consider for patients newly diagnosed with metastatic RCC.” 

Advances in treatment for metastatic RCC have dramatically changed the landscape for patients over the last decade and have resulted in increasing overall survival rates for the disease, which is the deadliest of all urological malignancies. 

“This therapy option will provide new hope for patients diagnosed with metastatic disease and is an important step forward in the fight against kidney cancer,” said Dena Battle, President of KCCure.  “We’re eager to share this news with patients and help educate the community about this new treatment approval.”

About KCCure: The Kidney Cancer Research Alliance (KCCure) is a grassroots organization of patients, caregivers, doctors and medical researchers dedicated to eliminating suffering and death due to kidney cancer through increased funding to accelerate research that will lead to a cure for all patients and prevent future kidney cancer diagnoses.

For more information about treatment options available for advanced kidney cancer, click here.



Dena Battle 


Follow us @kccure

Share This Post

Lost Password


Subscribe for updates!