FDA OKs New Kidney, GI Cancer Pill
Jan. 26, 2006 -- The FDA has approved a new drug called Sutent for two types of cancer.
Those conditions are:
Sutent is taken as a pill. It deprives tumor cells of blood and nutrients needed for growth. The drug is part of a class of drugs called tyrosine kinase inhibitors.
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.
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.
Those conditions are:
- Advanced kidney cancer (renal cell carcinoma)
- Gastrointestinal stromal tumors (GIST) that don't respond to another drug called Gleevec
Sutent is taken as a pill. It deprives tumor cells of blood and nutrients needed for growth. The drug is part of a class of drugs called tyrosine kinase inhibitors.
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.
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