- ‘Gay Jeans’ that fade into rainbow-colored denim created
- Divided court strikes down big porn award
- Jimmy Carter: Don’t hurt Russian people with sanctions
- Oldest ex-MLB player dies in Cuba, 2 days shy of 103rd birthday
- ‘Top Gun’ for drones: Squadrons of carrier-based killers have Navy’s approval
- Bill Clinton to endorse Charlie Rangel for re-election
- Pfc. Bradley Manning is now Pfc. Chelsea Manning: Court says so
- Secret base U.S. special forces used to train Libyans now under terrorist control: report
- 9th suspect in N.C. kidnapping turns self in to FBI
- L.A. sheriff admits to testing flyover spy program without notifying residents
FDA expands approval of J&J prostate cancer drug
WASHINGTON (AP) - The Food and Drug Administration on Monday expanded approval of Johnson & Johnson’s prostate cancer pill Zytiga for men with an earlier stage of the disease.
The agency says Zytiga is now approved for late-stage prostate cancer patients who have not yet received chemotherapy, based on study results showing it can extend life by up to five months when taken by men in that group.
The FDA previously approved the drug in April 2011 for men with prostate cancer who have already taken the chemotherapy drug docetaxel.
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.
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.
FDA cancer drugs chief Dr. Richard Pazdur said the FDA’s approval “provides patients and health care providers the option of using Zytiga earlier in the course of treatment.”
Common side effects with the drug include fatigue, joint swelling, diarrhea, vomiting, cough and shortness of breath.
Shares of Johnson & Johnson rose 10 cents to $70.55 in afternoon trading Monday.
TWT Video Picks
By Andrew P. Napolitano
Obama's veil of secrecy is pierced
- Pentagon plans to replace flight crews with 'full-time' robots
- 'Top Gun' for drones: Squadrons of carrier-based killers have Navy's approval
- Kansas will nullify local regulation of guns
- Nevada rancher Cliven Bundy hailed as patriot, ripped as lawless deadbeat
- America is an oligarchy, not a democracy or republic, university study finds
- Opposition rising to Colorado gun control laws
- CARSON: When government looks more like foe than friend
- Texas is next! AG warns BLM wants 90,000 acres after Bundy ranch standoff
- Harry Reid using tax dollars to fight Koch brothers, La. GOP chair charges
- Washington Redskins' 2014 schedule opens with Texans
Top 10 handguns in the U.S.
Celebrity deaths in 2014