Pfizer receives FDA approval for Sutent (sunitinib malate) as first and only adjuvant treatment for adult patients at high risk of recurrent renal cell carcinoma.
The U.S. Food and Drug Administration has approved a new indication expanding the use of Pfizer Inc.’s Sutent (sunitinib malate) to include the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancerous kidney).
The approval was based on results from the S-TRAC trial that demonstrated a significant reduction in the risk of a disease-free survival (DFS) event (defined as the interval between randomization and tumor recurrence, or secondary primary cancer or death from any cause) for patients at high risk of RCC recurrence who received Sutent compared to placebo in the adjuvant setting.
Sutent has been a standard of care for the treatment of advanced RCC since it was approved more than a decade ago, and is now the first approved adjuvant treatment option for certain patients at high risk of recurrent RCC — the most common type of kidney cancer. The current treatment approach for RCC patients is surgery followed by observation, which is suboptimal for patients at high risk of recurrence.
The S-TRAC trial was a multicenter, international, randomized, double-blind, placebo-controlled Phase 3 trial of Sutent versus placebo in 615 patients with clear cell histology and high risk of recurrent RCC following nephrectomy. The study met its primary endpoint of improving DFS and the results were published by The New England Journal of Medicine in October 2016.
“Some patients who have undergone surgery for locally advanced RCC are at high risk of recurrence and often fear their disease returning,” said Daniel George, M.D., study investigator and medical oncologist at Duke University Medical Center. “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.”
In the S-TRAC trial, the Hazard Ratio (HR) was 0.76 (95 percent CI: 0.59, 0.98) with a 2-sided p-value=0.03 in favor of Sutent, representing a statistically significant 24 percent relative reduction in the risk of a DFS event. The median DFS was 6.8 years (95 percent CI: 5.8, not reached [NR]) in the Sutent arm compared with 5.6 years (95 percent CI: 3.8, 6.6) in the placebo arm. At five years, the DFS rate for patients receiving Sutent was 59.3 percent and 51.3 percent for placebo. This represents a persistent 8 percent absolute benefit.
No new safety signals were identified in the S-TRAC trial. The most common adverse reactions occurring in ≥20 percent of patients receiving Sutent for adjuvant treatment of RCC (all grades) were mucositis/stomatitis (61 percent), fatigue/asthenia (57 percent), diarrhea (57 percent), hand-foot syndrome (50 percent), hypertension (39 percent), altered taste (38 percent), nausea (34 percent), dyspepsia (27 percent), abdominal pain (25 percent), rash (24 percent), hypothyroidism/TSH increased (24 percent), bleeding events, all sites (24 percent), and hair color changes (22 percent).
The prescribing information for Sutent also includes a boxed warning for hepatotoxicity and notes the following warnings and precautions: cardiovascular events; QT Interval Prolongation and Torsades de Pointes; hypertension; hemorrhagic events and viscus perforation; Tumor Lysis Syndrome (TLS); thrombotic microangiopathy (TMA); proteinuria; dermatologic toxicities; thyroid dysfunction; hypoglycemia; osteonecrosis of the jaw (ONJ); wound healing; and embryo-fetal toxicity.
(Source: Pfizer Inc.; Photo: Associated Press)
Filed Under: Drug Discovery
