The U.S. Food and Drug Administration’s oncology panel voted 6-6 on the potential approval of Pfizer’s Sutent (ingredient: sunitinib) to treat kidney cancer patients at high risk for reoccurrence after surgery.
The drug gained FDA approval in 2006 to treat advanced renal cell carcinoma (RCC) and has won approval in 119 countries, according to Pfizer.
The FDA Oncologic Drugs Advisory Committee was split on the risk-benefit of the drug to be used as an adjuvant therapy in RCC patients, who have received nephrectomy and are at high risk of recurrence.
The panel decision may cast a cloud on the final approval, market watchers said.
The panel vote was based on phase 3 S-TRAC clinical trial findings that showed the median disease-free survival (DFS) was extended by 6.8 years, 1.2 years more than the placebo arm.
The Sutent arm reported more Grade 3/4 adverse effects with a 41.7 percent point difference compared to the placebo (63.4 percent vs. 21.7 percent). The adverse effects included palmar-plantar erythrodysesthesia, or hand-foot syndrome (16 percent), neutropenia (8.5 percent), hypertension (7.8 percent), and thrombocytopenia (6.2 percent).
Also, 99.7 percent of patients in the sunitinib group experienced treatment-emergent adverse effects versus 88.5 percent in the placeboes. The most common adverse effects associated with the drug were diarrhea (56.9 percent), palmar-plantar erythrodysesthesia (50.3 percent), hypertension (36.9 percent), fatigue (36.9 percent), and nausea (34.3 percent).
The final approval decision will be made next January.
“We are encouraged by today’s productive discussion and look forward to working with the FDA over the next few weeks as they incorporate current debate into their review and decision regarding SUTENT in this patient population,” said Mace Rothenberg, the chief development officer of Pfizer Global Product Development.
SUTENT has long been a standard of care for the treatment of advanced RCC and Pfizer believes that this potential benefit can be extended to patients with high-risk of RCC recurrence, as demonstrated in the S-TRAC trial, he added.
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