Those conditions are:
- Advanced kidney cancer (renal cell carcinoma)
- Gastrointestinal stromal tumors (GIST) that don't respond to another drug called Gleevec
The approval is the first time the FDA has approved a new cancer product for two indications at the same time.
"Today's approval is a major step forward in making breakthrough treatments available for patients with rare and difficult to treat forms of cancer," says Steven Galson, MD, MPH, director of the FDA's Center for Drug Evaluation and Research, in an FDA news release.
"New targeted therapies, such as Sutent, are helping [the] FDA expand options for patients for whom there are limited alternatives," Galson says.
Sutent is made by Pfizer, a WebMD sponsor.
Drug's Approval for GIST
Sutent was approved for GIST patients whose disease worsens despite treatment with Gleevec or who can't tolerate Gleevec.
The approval was based on a study showing that Sutent slowed tumor growth. It took 27 weeks, on average, for tumors to progress in patients treated with Sutent, compared with six weeks for those not treated with the drug.
That finding came from an early analysis of data from a study comparing Sutent to a placebo, which contained no medicine. Based on the finding, researchers switched all patients to Sutent.
Sutent showed a "very significant advantage" in the trial, says Richard Pazdur, MD, director of the FDA's Office of Oncology Drug Products. Pazdur made the comment in a teleconference with reporters.
Drug's Approval for Advanced Kidney Cancer
The FDA gave Sutent accelerated approval for advanced kidney cancer (renal cell carcinoma). The decision was based on Sutent's ability to reduce the size of patients' tumors.
In patients with kidney cancer that had spread beyond the kidneys after other drug therapy, 26% to 37% responded to Sutent, states the FDA.
The medical reviewer who worked on those studies explained that those patients' tumors shrank by at least 50% over 54 weeks. Longer follow-up is under way; survival benefits haven't yet been shown.
"We really feel that this represents a therapeutic alternative for patients that have advanced renal cell carcinoma," Pazdur told reporters.
"There are clinical scenarios where we think that patients may benefit by using this drug, especially if they have localized disease, for example, or painful metasteses where reduction in tumor mass may be of importance," he continues.
Patients treated with Sutent also experienced, fatigue, high blood pressure, bleeding, swelling, and taste disturbance. Hypothyroidism (low production of thyroid hormone) was also observed in 4% of patients, says Pazdur.
Side effects were similar with the kidney and GIST cancer studies, Pazdur notes.