Comment 11 of 11, added on May 25th, 2013 at 6:24 PM.
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The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223
dichloride) to treat men with symptomatic late-stage (metastatic)
castration-resistant prostate cancer that has spread to bones but not to
other organs. It is intended for men whose cancer has spread after
receiving medical or surgical therapy to lower testosterone.
Prostate cancer forms in a gland in the male reproductive system found
below the bladder and in front of the rectum. The male sex hormone
testosterone stimulates the prostate tumors to grow. According to the
National Cancer Institute, an estimated 238,590 men will be diagnosed with
prostate cancer and 29,720 will die from the disease in 2013.
Xofigo is being approved more than three months ahead of the product¡¯s
prescription drug user fee goal date of Aug. 14, 2013, the date the agency
was scheduled to complete review of the drug application. The FDA reviewed
Xofigo under the agency¡¯s priority review program, which provides for an
expedited review of drugs that appear to provide safe and effective therapy
when no satisfactory alternative therapy exists, or offer significant
improvement compared to marketed products.
¡°Xofigo binds with minerals in the bone to deliver radiation directly to
bone tumors, limiting the damage to the surrounding normal tissues,¡± said
Richard Pazdur, M.D., director of the Office of Hematology and Oncology
Products in the FDA¡¯s Center for Drug Evaluation and Research. ¡°Xofigo is
the second prostate cancer drug approved by the FDA in the past year that
demonstrates an ability to extend the survival of men with metastatic
In August 2012, the FDA approved Xtandi to treat men with metastatic
castration-resistant prostate cancer that has spread or recurred, even with
medical or surgical therapy to minimize testosterone. Xtandi is approved
for patients who have previously been treated the chemotherapy drug
Xofigo¡¯s safety and effectiveness were evaluated in a single clinical
trial of 809 men with symptomatic castration-resistant prostate cancer that
spread to bones but not to other organs. Patients were randomly assigned to
receive Xofigo or a placebo plus best standard of care.
The study was designed to measure overall survival. Results from a
pre-planned interim analysis showed men receiving Xofigo lived a median of
14 months compared to a median of 11.2 months for men receiving placebo. An
exploratory updated analysis conducted later in the trial confirmed
Xofigo¡¯s ability to extend overall survival.
The most common side effects reported during clinical trials in men
receiving Xofigo were nausea, diarrhea, vomiting and swelling of the leg,
ankle or foot. The most common abnormalities detected during blood testing
included low levels of red blood cells (anemia), lymphocytes
(lymphocytopenia), white blood cells (leukopenia), platelets
(thrombocytopenia) and infection-fighting white blood cells (neutropenia).
Comment 10 of 11, added on April 20th, 2013 at 1:29 AM.
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Comment 9 of 11, added on March 5th, 2013 at 3:47 AM.
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Aw, this was a certainly nice post. In idea I would like to put in writing
like this furthermore - taking time and actual effort to make a extremely
wonderful article?- but what can I say?- I procrastinate alot and by no
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Comment 8 of 11, added on October 10th, 2012 at 4:09 PM.
I think the old patch of snow was an old conversation and it has been
brought up again and was forgotten. The newer thinks You are able to
remember but older things are hater to remember.
Trey from United States
Comment 7 of 11, added on October 30th, 2011 at 11:18 PM.
old patch of snow by robert frost
i seem to be in a disagreement with quite a few people... i think this poem
is about something that was once so little and insignificant at the
time,but later it became something important, and now you regret over
Comment 6 of 11, added on February 4th, 2009 at 9:28 AM.
I don't think this poem has a "message." It's not "about" anything. It
presents an image, a metaphor, a comparison of dirty old snow and a wet old
newspaper blown into a street corner. The strength and pleasure in the
poem is in this surprisingly apt comparison. Both the dirty old patch of
snow and the wet old newspaper are left-overs whose day has past.
Sam from United States
Comment 5 of 11, added on March 15th, 2006 at 1:56 PM.
i didn't take this poem the way anyone else i see did. Maybe i don't quite
understand what they are saying. Anyway, I thought Robert Frost was saying
we take thing for granted and dont appreciate them. We wait until their
old and ugly to think about how they are just in the way. We forget they
were once so pretty, and now they are just forgotten.
Tina from United States
Comment 4 of 11, added on February 9th, 2006 at 6:22 PM.
i belive this poem means that older things are nto treated as nicely as
younger things,for example the homeless,everyone cares about the homeless
youth and pay almost no attention to the elderly.
worth from United States
Comment 3 of 11, added on July 30th, 2005 at 1:31 PM.
Sometimes we overlook what is in front of us. It is easy to dismiss the
words of a fool. Paying attention is the way to realization.
CP from United States
Comment 2 of 11, added on May 24th, 2005 at 9:08 PM.
Awesome poem. How often we do not notice how quickly life changes around
us: either the changes in the seasons or the news of yesterday.
cody d'amours from Canada
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