FDA expands use of Pfizer's Sutent in kidney cancer

Pfizer has announced that the FDA has expanded the use of its tyrosine kinase inhibitor Sutent (sunitinib malate) to include the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) – the most common kind of kidney cancer – following nephrectomy (surgical removal of the cancerous kidney).

The decision was made after the drug demonstrated the ability to significantly reduce the risk of disease-free survival events as an adjuvant treatment compared to placebo in the 615-participant S-TRAC trial.

Sutent has been a standard of care treatment for advanced RCC for over a decade. Liz Barrett, Global President and General Manager, Pfizer Oncology, remarked on the approval: "Today’s approval marks an important step forward for the treatment of adult patients who are at high risk of their renal cell carcinoma returning after surgery," "Pfizer has been dedicated to advancing the science of RCC treatment for over a decade, and we are pleased to see this commitment continue to translate into meaningful options for patients."

Daniel George, study investigator and Medical Oncologist at Duke University Medical Center, added: "Some patients who have undergone surgery for locally advanced RCC are at high risk of recurrence and often fear their disease returning. This adjuvant therapy is the first-of-its-kind and a remarkable clinical development for these patients who before today, have been restricted to a wait and see approach."