Pfizer Korea said Friday it got an additional indication for its renal cell carcinoma drug Sutent (sunitinib malate) to be used in adult patients at high risk of recurrent RCC who’ve had nephrectomy.
The approval from the Ministry of Food and Drug Safety makes Sutent the first kidney cancer drug to gain an indication as an adjuvant therapy to be used after RCC surgery.
Sutent had gained indications to treat progressive RCC, gastrointestinal basal tumors failing imatinib mesylate therapy due to resistance and tolerability, and unresectable and highly differentiated advanced and metastatic pancreatic endocrine tumors.
The expanded approval was based on a multicenter, international, randomized, double-blind, placebo-controlled Phase 3 S-TRAC study on 615 patients at high risk for recurrent RCC. In the study, patients who underwent nephrectomy were split into a Sutent and placebo group.
Findings showed the Sutent group had a median disease-free survival rate of 6.2 years, which was higher than the four years of the placebo group.
However, the S-TRAC study also found that adverse events above Grade 3 were higher in the Sutent group. Patients in the Sutent arm had a 63 percent rate of Grade 3 AEs while those in the placebo arm had 21 percent.
Several adverse events, including neutropenia, were reported, and the incidence of temporary treatment suspensions and dose reduction due to adverse events were higher in the Sutent medication group. The discontinuation rate was also higher in the Sutent arm.