FDA Expands Approval for Zytiga as Late-Stage Prostate Cancer Drug

December 12, 2012 by  
Filed under Prostate Cancer News

Zytiga, a prostate cancer drug manufactured by Johnson & Johnson has received as expanded approval from the US Food and Drug Administration (FDA).

The expanded approval means that the drug can now be used to treat prostate cancer patients with late-stage symptoms.

The initial approval for Zytiga is for it to be used for men with earlier stage prostate cancer. This approval was made in April 2011.

In the latest development, Zytiga can be administered to men with late-stage prostate cancer, and who has not received chemotherapy drug before. In the earlier case, the drug can be administered after the patient has taken the chemotherapy drug Docetaxel.


A publication in ABC News December 10, 2012 reveals that:  Zytiga works by decreasing the male hormone testosterone. Testosterone stimulates the growth of prostate tumors, and treatment often includes drugs aimed at cutting the body’s testosterone production. While older drugs can block about 90 percent of the hormone, scientists say Zytiga blocks virtually all of it, which can help slow the disease.

Photo: Google Image

The FDA approved the new indication based on a J&J study of 1,088 men with late-stage prostate cancer who had not already received chemotherapy.

The typical patient taking Zytiga survived five months longer than the typical patient taking a fake pill, or placebo.

When the study was stopped, the median time until cancer worsened in the group getting dummy pills was about eight months. Those on Zytiga were faring much better, so researchers could not yet report how long it would take their cancers to worsen.

Conclusively, Zytiga provide men with fresh options of having their conditions treated early, however in using this medication, its side effects should not be ignored. Common side effects include: shortness of breath, cough, vomiting, diarrhea, joint swelling, and fatigue. You can have thorough discussions with your doctor on this treatment.

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