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Posts with tag approval
Posted Jul 13th 2007 6:00PM by Kristina Collins
Filed under: Drug, All Cancers
A generic drug is exactly the same dosage, safety, strength and quality as a brand named drug. Generic drugs also do not take longer to work in the body, again, its the same ingredients as the name you are more familiar.
The reason generic drugs are cheaper is because the makers of these drugs don't have the costs of the original developer of the drug. When the patent on the developer expires, 20 years, other manufactures can introduce competitive generic versions to the FDA for approval. This also creates greater competition in the industry once generic drugs are approved and keeps costs lower.
A great place to go is here for more information on your generic drugs.
Posted Jun 4th 2007 8:00AM by Jacki Donaldson
Filed under: Drug, Kidney Cancer, Research, Daily news

New cancer drug Torisol was
approved on Wednesday by the FDA for use with renal cell carcinoma, an advanced form of kidney cancer.
Torisol, also known as temsirolimus, is an enzyme inhibitor made by Wyeth Pharmaceuticals and has shown promise for prolonging patient survival. It's the third kidney cancer drug approved in the past 18 months -- the other two are Nexavar, intended to delay disease progression, and Sutent, for tumor size reduction.
Many kidney cancer patients are cured by surgery. About 35 percent of patients, however, experience a recurrence or a spread of the disease. Until just recently, there were no effective drugs to control these issues. Now there are several -- and Torisol is the one showing modest improvement in survival for patients with the most advanced tumors. Further study will indicate whether or not the drug is useful for patients with less extensive metastatic disease.
Posted Feb 17th 2007 10:00AM by Jacki Donaldson
Filed under: Kidney Cancer, Liver Cancer, Clinical Trials, Research, Daily news

Cancer drug Nexavar has made its point. It can help people with liver cancer survive longer.
Bayer Pharmaceuticals and Onyx Pharmaceuticals announced Monday that advanced stage clinical trials for this drug will end early. And now patients in the placebo arm of the study can begin treatment with the actual drug.
It's been a long road for researchers who have been searching for a liver cancer treatment that can target tumors with minimal side effects while extending life for months or even years.
It is estimated that 16,780 people in the United States will die from liver cancer in 2007 -- and it seems Nexavar, a drug initially predicted to fail when used for liver cancer -- may help save some of these lives.
Bayer and Onyx are planning to pursue FDA approval for this drug that has already been approved for kidney cancer.
Posted Feb 7th 2007 9:00AM by Jacki Donaldson
Filed under: Breast Cancer, Research, Products, Daily news

Women with early stage breast cancer now have a new tool at their disposal. The tool -- called MammaPrint -- is newly approved by the FDA and while it is not yet a perfect measure, it can be used along with other information to estimate whether breast cancer is likely to return in five or 10 years.
The value of this test, that measures through computer analysis the activity of 70 genes using a sample of tissue removed from a breast tumor, is that doctors and patients can better determine course of treatments.
MammoPrint offers two results --
high risk and
low risk -- and accurately picked in studies which women were at low risk at least 90 percent of the time. However, for women who were told they were at high risk for recurrence as a result of the test, just 23 percent experienced a relapse.
"You can't go all the way to the bank with this test," says FDA official Dr. Steven Gutman who argues the test is still better than having no information at all.
Agendia, the Dutch maker of MammoPrint, is exploring ways to make this one-of-a-kind product available in the United States. It has been used in the Netherlands since 2005.
"This test has enormous implications for the short-term future of cancer research in general, and is one of the truly great breakthroughs of our time," says
Cancer Blog reader Gregory Pawelski with whom I am grateful for sharing this story tip with me.
Posted Feb 6th 2007 10:00AM by Jacki Donaldson
Filed under: Breast Cancer, Research, Daily news

If the experimental breast cancer drug Tykerb continues to prove successful in study participants, it could be headed for FDA approval.
Tykerb, now in international study, showed in early studies to be even more effective and to have fewer side effects than similar breast cancer drug Herceptin. Both drugs are part of a cluster of targeted therapies that attack cancer cells while sparing healthy cells. Designed for use on women whose breast cancer is HER2 positive -- meaning it contains too much of an aggressive protein -- Tykerb may be a wonder drug, with the capability of effectively keeping breast cancer at bay.
Dr. Paul Goss of MA General Hospital says, "We're seeing Tykerb, which is a pill, which is easier to take, has a broader attack and gets inside cells. It's like an electrical circuit that's turned on, and Tykerb can pull the lever, the circuit breaker, and switch it off."
Posted Dec 28th 2006 3:40PM by Kristina Collins
Filed under: Drug, Chemotherapy, Prevention, All Cancers
Zofran (Ondansetron) tablets are used to prevent nausea and vomiting associated with chemotherapy. I remember Zofran costing about $30 a tablet back in 2002 when I was receiving chemotherapy. I was lucky I had insurance that covered the high cost of the drugs I needed. Yesterday the Food and Drug Administration approved the first generic versions of Zofran.
Gary j. Buehler, director, Office of General Drugs, says "This approval will result in significant savings for the American public. Generic drugs are safe and effective alternatives to brand name drugs and undergo a thorough scientific and regulatory review".
Generic drugs usually cost a fraction of the price of the brand-name drugs.
Posted Oct 21st 2006 9:00AM by Jacki Donaldson
Filed under: Breast Cancer, Drug, Chemotherapy, Daily news

The breast cancer drug Tykerb may be one of the future wonder drugs available for women left with limited options for treating advanced-stage disease.
Tykerb, manufactured by British-based GlaxoSmithKline PLC, is currently an experimental drug that delays growth of tumors nearly twice as long as standard chemotherapy in patients who no longer respond to Herceptin -- a targeted drug that significantly decreases chances of recurrence for women with HER2 positive breast cancer. Herceptin blocks the swift growth of an aggressive protein on the cell's surface while Tykerb does its work on the inside of the cell. Herceptin is given intravenously. Tykerb is given in pill form.
Two previous posts -- one in
April and one in
June -- relfect the progress of Tykerb as reported in the media. With each new report, Tykerb seems to gain momentum and promise. And this past week, new reports revealed new promise as Glaxo began seeking regulatory approval of the Tykerb pill in Europe.
Glaxo has filed an application with the Food and Drug Administration for approval of this drug and is preparing to market the drug for the treatment of advanced breast cancer in women. Glaxo hopes to launch Tykerb -- also known as lapatinib ditosylate -- next year.
Posted Sep 28th 2006 12:00PM by Kristina Collins
Filed under: Drug, Colon and Rectal Cancer, Research, Cancer Survivors
Yesterday the Food and Drug Administration approved the drug Vectibix for patients who have metastatic colon cancer. Vectibix is to be given by IV following standard chemotherapy treatments. The FDA approved the drug after it showed effectiveness in slowing tumor growth and, in some cases, reduced tumor size.
Steven Galson, MD,MPH, the director of the FDA's Center for Drug Evaluation and Research said "This approval adds a treatment option for patients with an advanced stage of a disease that can be life threatening".
Vectibix is a monoclonal antibody, scientists can make monoclonal antibodies that react with specific antigens on certain types of cancer cells. As researchers discover more cancer associated antigens, they will be able to direct monoclonal antibodies against more and more cancers.
Posted Jul 9th 2006 1:33PM by Dalene Entenmann
Filed under: Breast Cancer, Prevention, Celebrity cancer diagnosis, Diets, Stress Reduction, Nutrition, Cancer prevention foods, Television, Celebrity news

In the second part of the two-part exclusive interview with ABC's Good Morning America Diane Sawyer, Sheryl Crow shares she is cancer-free and feeling great as a breast cancer survivor. The diagnosis of breast cancer came as a surprise as she is not a smoker and has no family history of the disease. She received enormous support from her family and friends during treatment, whom she refers to as "this incredible tribe of women." Before Dana Reeve died of lung cancer, she gave Crow advice on dealing with the emotional aspects of being a newly-diagnosed cancer patient and dealing with the recent separation from Lance Armstrong by telling her that the only way to go through grief was to grieve.
Crow talked about meditating and changing her diet. "I kind of went into a full-on Eskimo diet, where I ate a lot of salmon. In fact, I'm salmoned out of my brains ... and really green vegetables, just eating really clean, organic food. Listen, I haven't had a doughnut in I can't remember when."
Breast cancer forced Crow into an introspective place of self-realization in facing and overcoming fears -- and the wisdom that comes with that when she said she tried to at least address her fears and not be overcome by them. "The fear of things not always working out. You come to a point in your life where you realize it's not my job to prove to my parents or to my record label or to the world or to my lover that I matter.
The fact is that you matter."
"It's not a good place to be concerned with always being right with everybody, always pleasing people, because ultimately you wind up betraying yourself a lot."
Crow shared that she sees her breast cancer diagnosis and being a cancer survivor as part of life's deepening experiences where obstacles are removed and opportunities come in.
Last Friday night, Crow joined the Dave Matthews Band in a concert at Fenway Park. But before she went onstage -- in part of giving back as a cancer survivor -- she made an unannounced surprise visit to Boston's Dana-Farber Cancer Institute to visit children with cancer at the
Jimmy Fund Clinic.
Posted Jul 1st 2006 2:22PM by Dalene Entenmann
Filed under: Skin Cancer, Melanoma, Prevention

Dimericine, a lotion created to be used the day after a sunburn to protect against some forms of skin cancer, might
win FDA approval in the next two years. It's not a magic bullet that allows sun worshippers to return to the old ways of tanning without consequence. Spend too much time in the sun and wrinkles are inevitable. The pain of a sunburn will still hurt even using this new cream. And skin cancer is still a risk -- perhaps just less so.
Dimericine is more of an emergency morning after measure, if you spend more time in the sun than you should the day before and have a burn as a result, or you missed a spot when applying the sunscreen lotion and were not aware until it was too late to prevent the sunburn. The cream will repair some of the damage to the skin a sunburn causes. If the cream is approved, and becomes available, experts still recommend that all the sun safety rules be followed when spending time in the sun. Sunscreen, wide-brimmed hat, sunglasses, long sleeves, seeking shade and staying out of the sun during peak hours between 10 am and 4 pm.
To read more on how and why to practice sun safety, go to
skin cancer prevention kits for kids,
shading kids from the sun, and
pediatricians need to educate parents about sun exposure risks.
Posted Jun 16th 2006 7:00AM by Dalene Entenmann
Filed under: Drug, Chemotherapy, Cervical Cancer, Daily news

Every promising drug therapy has a potential dark side. Hycamtin -- topotecan hydrochloride -- a cancer-fighting drug used to treat patients with ovarian and lung cancer, has received
FDA approval for treatment of late-stage cervical cancer. When surgery or radiation is not a viable option for women diagnosed with recurrent or incurable cervical cancer, Hycamtin can be added to cisplatin as a combination chemotherapy drug therapy shown to provide life-lengthening benefit.
Combining Hycamtin with cisplatin is not a cure, and in clinical trials showed an additional survival benefit of three months when compared to treatment with cisplatin alone. Who would not choose to live as long as possible, even if you are measuring life in months? However, the combination drug therapy is likely to increase the risk in lowering white cell counts, decreasing blood platelets, inducing nausea, vomiting, diarrhea and hair loss. Quantity of life versus quality of life is the dark side of this drug therapy promise. One woman might choose quantity of life, and another woman choose quality of life. There is no wrong or right but when making a choice it needs to be made with eyes wide open.
For more information, there is a
Hycamtin website offering information on how the chemotherapy drug is administered and the side effects a woman can expect during treatment. While it is written for ovarian and lung cancer patients, I believe the basic over all information should be the same for cervical cancer patients.
Thanks to Joel Arellano of Autoblog for this news tip!Posted Jun 9th 2006 9:00AM by Dalene Entenmann
Filed under: Drug, Prevention, Cervical Cancer

In 2004, Women In Government launched its
Challenge to Eliminate Cervical Cancer Campaign, to raise awareness about cervical cancer and human papillomavirus, HPV. The organization applauded the FDA approval of Gardasil, the first cervical cancer vaccine, for girls and women between the ages of 9 and 26. To guarantee that all girls and women have access to the new cervical cancer vaccine, they are urging the federal Advisory Committee on Immunization Practices to include the new cervical cancer vaccine in the federal government's Vaccines for Children Program, which provides free immunization for under-insured and uninsured children.
Women In Government president Susan Crosby stresses the continued importance of annual pap tests and screening in the early detection of cervical cancer caused by HPV in women who have already been exposed to the virus.
Posted Jun 8th 2006 4:23PM by Dalene Entenmann

It is official. The
first cervical cancer vaccine has been approved by the Food and Drug Administration, FDA. Merck's Gardasil cervical cancer vaccine is the first of several cancer vaccines expected to win approval this year. Gardasil, which targets human papillomavirus, HPV, will be given in three doses over six months. HPV is known to be responsible for the majority of cervical cancer cases.
The cervical cancer vaccine is not without its warnings though. In an earlier post,
cervical cancer vaccine protects and promotes cancer, we noted a caution that research has shown the vaccine can actually raise the risk of cervical cancer if the woman is already infected with HPV at the time she receives the cervical cancer vaccine. So, it is not for every woman.
We also noted in an earlier post,
cancer vaccine facing Christian Right opposition, there is strong objection to the cervical cancer vaccine based on religious convictions regarding sex and teenage girls. According to experts, girls in their early teens are the most likely to benefit from the cervical cancer vaccine.
Posted Jun 7th 2006 5:07PM by Dalene Entenmann
Filed under: Drug, Prevention, Cervical Cancer, Oral Cancer, Research, Daily news

Gardasil, the cervical cancer vaccine expected to receive FDA approval any day now, and proven to provide women 100 percent protection against cervical cancer, might also offer the same level of
protection against vulvar and vaginal cancers. Finnish researchers of the study that made the discovery note that while vulvar and vaginal cancers are less common than cervical cancer, more younger women are being diagnosed with vulvar and vaginal cancers.
The cervical cancer vaccines set to be approved this year guard against human papillomavirus, HPV -- a virus known to lead to cervical cancer. HPV is responsible for all cases of cervical cancers and is present in 80 percent of the 6,000 cases of vaginal and vulvar cancers diagnosed in the United States each year.
In a separate study, Dana-Farber Cancer Institute researchers have announced that the cervical cancer vaccine might lead to less cancer of the head and neck. "If we vaccinate everybody in the U.S., we could probably impact head and neck cancer in approximately 20 years," said Marshall Posner, director of the head and neck oncology program at Dana-Farber Cancer Institute in Boston.
Posted May 17th 2006 5:33PM by Dalene Entenmann
Filed under: Drug, Prevention

A meeting between the FDA and an FDA advisory panel is set for tomorrow to discuss the safety and effectiveness of Gardasil, a Merck experimental vaccine the protects women from human papilloma virus, HPV -- a leading cause of cervical cancer. It is being reported that the FDA normally follows the FDA advisory panel advice in deciding which drugs to approve, and the FDA advisory panel has given
a thumbs up for the new cervical cancer vaccine. There is a note of caution. Research has shown that the vaccine can actually raise the risk of cervical cancer if the woman is already infected with HPV at the time she receives the cervical vaccine.
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