Comment 9 of 9, added on May 25th, 2013 at 12:04 PM.
Gains for a 4th Week in a Row, and Milestones, Too ujm
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
prostate cancer.¡±

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
docetaxel.

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).

12312
12312

gandigoBligma from Ghana

Comment 7 of 9, added on May 25th, 2013 at 9:44 AM.
Pregnant Beyonc¨¦: See Fashion Photos From When She Was Expecting Blue Ivy wbd
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
prostate cancer.¡±

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
docetaxel.

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).

12312
12312

gandigoBligma from Algeria

Comment 5 of 9, added on December 5th, 2011 at 10:18 AM.

i dont understand.

Tim

Comment 3 of 9, added on January 28th, 2010 at 12:00 AM.
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hotel in der tuerkei

Comment 1 of 9, added on February 14th, 2005 at 12:46 PM.

Names do not mean the same thing to all people, but usually are given in
the memory of others. The name Maple was actually given to the father as a
gift of her (mother's) own memory, so that the father would always see her
in the daughter. The symbolism is that a maple tree in autumn is a
beautiful birth of colors before the death of winter. This mircle of
beauty recurs every year before the dying of the leaves. The same is true
for Maple, who is the rebirth of her mother; the cycle of life.
It is also interesting that trees have long been considered sacred by
ancient cultures. Perhaps because of their long life span and rebirth
through the seasons. The Druids for example, believe that some trees
contain the spirits of the deceased.

Jon from United States