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BY KATHY LATOUR | MAY 5, 2012
I rode the shuttle to the early sessions at the Oncology Nursing Society congress this morning, and my conversation with the nurse in the window seat has given me some new perspective on those nurses who are at the bedside of dying cancer patients. We were chatting about which sessions we had attended. Well, actually, I was sort of interviewing her about what she had learned from the meeting, when I saw from her badge that she was a first-time attendee. She said that the poster sessions, where nurse researchers make large posters of their studies, gave her some great ideas that could easily be transferred to her hospital and her job. When I asked what role she served, she said she was a bedside hematology nurse in the stem cell transplant area, and a good portion of her time was spent with very sick patients and their families. Because I know that this area is also one with a high mortality rate, I asked her which of the sessions she had attended and, not unexpectedly, she said she had attended the pre conference workshop on end of life. This overflow workshop explored the issues surrounding that time of transition from this world to the next, and, for those nurses who experience end of life more often in their jobs, it brings with it the need for special skills and the ability to self heal.
I can't imagine how hard it is to keep an open heart to the pain of being present for your patients' deaths and then be expected to walk to the next room where a patient is preparing to go home.
This nurse was struggling with the challenge of creating the relationship needed to spend the last week of a patient's life with them when she wanted to be part of the whole continuum of care. She was looking for ways to spend more time with her dying patients and the family. On that short bus ride, I saw once again how oncology nurses constantly think about ways to be closer to their patients. We parted ways with her talking about how she would share what she had learned with the other nurses in her area when she returned. Wow.
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BY LENA HUANG | APRIL 27, 2012
The American Cancer Society released new guidelines that recommend good nutrition and exercise for survivors to reduce the chance of recurrence and increase the possibility of disease-free survival. The ACS formulated these recommendations after convening a group of researchers and thought leaders in nutrition, exercise and cancer survivorship to evaluate current evidence and best practices on these topics. Among the committee's recommendations:
Minimizing weight gain during treatment may be important for survivors who are overweight and also for those of normal weight.
Evidence suggests that exercise is not only safe during cancer treatment but can also improve physical functioning, quality of life, fatigue and may even increase the rate of completion of chemotherapy.
Exercise after cancer diagnosis is associated with a reduced risk of recurrence and improved mortality in many cancer survivor groups, including breast, colorectal, ovarian and prostate.
Results of observational studies suggest diet and nutrition may affect risk of recurrence, cancer progression and overall survival in those treated for cancer.
This report also specifies nutrition and exercise advice by cancer types including breast, colorectal, endometrial, ovarian, lung, prostate, head and neck, and hematologic cancers. It also includes a helpful section on common questions and answers about nutrition, exercise and cancer survivorship. Some questions covered are:
Should alcohol be avoided during treatment? (Generally yes, or kept to a minimum, based on type and stage of disease.)
Are organic foods recommended for cancer survivors? (At present it is not known if organic foods are more effective in reducing recurrence than foods produced by other farming methods.)
Does sugar feed cancer? (No, however products high in added sugar may add substantial calories, resulting in weight gain, which may affect cancer outcomes.)
Can dietary supplements reduce the risk of recurrence? (No evidence at this time suggests supplements will reduce the chances of recurrence.)
Should I exercise during cancer treatment? (Evidence suggests that exercise is safe and can improve physical functioning and quality of life, however, intensity and duration may need to be adjusted during treatment and special precautions taken for those with anemia, weak immunity, bone disease, skin sensitivity, neuropathy and other side effects of therapy.)
"While we've published previous reports outlining the evidence on the impact of nutrition and physical activity on cancer recurrence and survival, this is the first time the evidence has been strong enough to release formal guidelines for survivorship, as we've done for cancer prevention. Living a physically active lifestyle and eating a healthy diet should absolutely be top of mind for anyone who's been diagnosed with cancer," Colleen Doyle, MS, RD, ACS director of nutrition and physical activity and co-author of the guidelines, said in a press release.
To read the full report, click here.
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BY LINDSAY RAY | APRIL 27, 2012
For decades, there hasn't been a new drug approved for sarcoma, but on April 26, the Food and Drug Administration approved Votrient (pazopanib) for patients with advanced soft tissue sarcoma who have received at least one prior chemotherapy treatment. However, the drug is not for patients who have adipocytic soft tissue sarcoma and gastrointestinal stromal tumors (GIST). Votrient was previously approved in 2009 for advanced renal cell carcinoma.
There are two main types of sarcomas--those that develop in the bones and those that develop in the soft tissues of the body, such as fats, muscles, nerves and more. Soft tissue sarcomas can occur anywhere in the body, but most develop in the arms or legs. While there are around 50 different subtypes, only about 11,000 cases are diagnosed each year, making this a rare tumor-type. Votrient is a tyrosine kinase inhibitor that works by inhibiting proteins that either help with the growth of new blood vessels that feeds these tumors or tell the tumor cells to grow and divide. It's a tablet taken once a day, without food, so either an hour before or two hours after a meal.
The drug was approved based on a phase 3 randomized, multicenter trial in which 369 patients were assigned to either receive Votrient or a placebo. Those in the Votrient arm had a median of 4.6 months progression free survival compared with the 1.6 months for those on placebo. Trending to improvement over the interim results announced at last year's meeting of the American Society of Clinical Oncology, median overall survival was still insignificant: 12.6 months for those on Votrient and 10.7 months for patients on placebo.
Common side effects included diarrhea, nausea, vomiting, decreased appetite and weight loss, hypertension, hair and skin changes, tumor pain, musculoskeletal pain, headache, shortness of breath, taste changes and fatigue, among others. Votrient also carries a boxed warning for the potential risk of liver damage, which can sometimes be fatal, so patients should be monitored for liver function. Other serious side effects include hemorrhage, gastrointestinal perforation, perforated lung and thrombotic events, such as a heart attack.
Other drugs in development for sarcomas include ridaforolimus, which was rejected by the same advisory panel that recommended Votrient for approval, ombrabulin, brivanib and Yondelis.
For more information, visit gsk.com call 888-825-5249.
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BY DEBU TRIPATHY | APRIL 9, 2012
In an unusual move, several professional societies jointly released a set of principles entitled "Choosing Wisely" (see choosingwisely.org) – five tests and treatments for each of several specialties that physicians and patients should question. Things that eventually cause more harm than good and also tend to drive up healthcare costs. The ones that are listed for cancer are available at: choosingwisely.org/wp-content/uploads/2012/04/5things_12_factsheet_Amer_Soc_Clin_Onc.pdf.
While these recommendations will need to be tailored to individual situations, they have the common theme that these tests that are done for "reassurance" or early detection of recurrence or metastasis of cancer when the chances of having a positive test are low, even lower than the chances of "false-positive" results that commonly lead to further testing or even harmful procedures. Also, there are two recommendations to avoid medical treatments (white blood count boosting drugs and chemotherapy for advanced cancers) in situations where there is no proven benefit. However, there is certainly going to be vocal opposition and there are already some who are criticizing this as some type of healthcare rationing. In particular, the recommendation to withhold chemotherapy in patients who have almost no chance of being helped by such treatment will be hard for many to accept.
This illustrates one of the key dilemmas of medical care and one of the reasons that our healthcare costs are the highest in the world whereas our health outcomes are clearly not the best. In the U.S., doctors and patients are quick to request tests and procedures that on the average may yield a very small chance of benefit and a greater chance of unnecessary treatment. But if you happen to be one of the rare patients that is helped by one of these tests, your viewpoint may be different. At the moment, the public (and most lawmakers who are elected by the public) have no appetite for advocating any restrictions on what a doctor and patient feel is the best course of care. But as patients are burdened with more costs of insurance and co-pays, they are starting to "self-ration" care.
In the last couple of years, more patients are opting to defer test and even cancer treatments mostly because of cost. Despite the controversy this movement will stir, it is clear that patients and physicians need to have information available to prioritize what test and treatments can be omitted without any (or minimal) change in outcome. But will our society be willing to accept these statistics and forgo the long shot?
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BY ELIZABETH WHITTINGTON | APRIL 1, 2012
After spending a few days at the American Association for Cancer Research annual meeting, I'm leaving with a feeling of optimism. There are great things happening in cancer research. The amount of knowledge and information our cancer researchers are finding is astounding, and it's increasing exponentially.
Unfortunately, in this time of budget cuts and conservative spending, the money spent on cancer research has remained flat over the past decade. And when you consider inflation, that's a 20 percent lower purchasing power -- roughly $6 billion. That means fewer grants, fewer researchers, fewer studies, fewer results. AACR has noted that cancer research funding remains its No. 1 priority. (AACR Board of Directors Pronounce Crisis in Cancer Research Funding its No. 1 Priority)
Many of the studies I've been learning about during this meeting are preclinical or early-phase human trials. While the big news comes out of ASCO, the annual meeting for the American Society of Clinical Oncology, which will highlight studies that may change clinical practice, AACR is the starting point. What I'm learning about at this meeting may ultimately make headlines in a year or two or three at ASCO.
Another great opportunity at this meeting is to learn about the next step, the next question. Researchers begin with a hypothesis, study it and present the results. You can almost bet on it, but after every press briefing, someone always asks, "What does this mean for the patient?" or "Will this change clinical practice?" Often times, the answer is no ... at least not yet. Researchers will ask more questions, building on this information, perform larger studies and ultimately, if it works out, it will change practice. That's why this basic cancer research is so important.
I've listened to quite a few studies in just these past two days that I'm hoping I'll hear more about at ASCO, including a potentially promising new lymphoma drug, the effects of metformin in prostate cancer, and the possibility that certain women with breast cancer may not need radiation therapy, among other interesting studies that I'll be reporting on soon.
I've included the opening video from the meeting. It emphasizes the importance of cancer research and explains where some of the greatest recent discoveries started.
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BY KATHERINE LAGOMARSINO | FEBRUARY 22, 2012
Some 31,000 units of preservative-free methotrexate, equivalent to a month's supply of the drug for the entire nation, are currently on their way to hospitals around the country, said Michael Ball, CEO of the drug manufacturer Hospira, in a Food and Drug Administration (FDA) press conference on Tuesday.
"Next week," said Ball, "we'll release 34,000 vials, another month's worth. By mid-March, we'll release another 55,000 vials."
Hospira is one among a handful of drug manufacturers picking up the slack for the nation-wide shortage of this life-preserving drug used for the treatment of acute lymphoblastic leukemia (ALL), the most common type of childhood cancer that is 90 percent curable with regular injections of methotrexate.
Last Friday, APP, another drug manufacturer, received FDA approval to produce preservative-free methotrexate and will begin supplying clinicians in the next four to six weeks. Two other manufacturers, Mylan Pharmaceuticals and Sandoz, have also agreed to ramp up production.
The FDA also announced in yesterday's briefing that they have found a substitute for Doxil (doxorubicin) a drug used to treat various forms of ovarian and lung cancers. Lipodux, produced by manufacturer Sun Pharma Global FZE, will temporarily replace Doxil, which has been in short supply since July.
While this news certainly comes as a relief to parents, healthcare providers, and of course, the patients whose very survival depends on methotrexate or Doxil, many say this situation is sure to happen again. "The system is fragile," said Peter C. Adamson, MD, the current chair of the Children's Oncology Group, who sat on the panel at yesterday's briefing. "For many of these drugs, there may be a sole provider. There are potential future crises that are waiting to happen."
In October, President Obama issued an executive order instructing drug manufacturers to report potential shortages to the FDA in a timely fashion so the agency has time to find other drug alternatives. In addition, the FDA said it was working on developing even tougher legislation that would create permanent solutions for these recurring drug shortages, although the agency admits these shortages stem from complex issues that include the problem of demand outpacing supply, particularly when it comes to generic drugs that have lower profit margins than brand name drugs, as well as other economic and legal issues.
Adamson concluded the nearly hour-long briefing with a comment that perhaps resonates most with the general public. "I understand that passing legislation is a complex and difficult process, but no more difficult than curing a child with cancer."
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BY KATHERINE LAGOMARSINO | FEBRUARY 14, 2012
I recently joined CURE as managing editor of books and special projects. While I have been in journalism for many years now, this is my first foray, as an editor, into the complex world of cancer. But as a daughter--well, that's a different story.
During one of my first staff meetings here, someone brought up the often-used analogies to describe the cancer experience: a battle, a journey, a roller coaster. But when I think of cancer, I always envision it as a marathon, admittedly, another well-worn metaphor. Perhaps that's because my father was an avid runner. He finished seven marathons in his lifetime, counted Chariots of Fire as one of his favorite movies (the theme song was one of his favorite songs), and he even founded a nine-mile running race in our hometown.
But in April 2000, my father's real marathon began when he was diagnosed with metastatic melanoma. The doctors figured it was from a large malignant mole he had removed from his leg 15 years prior, but that was only a guess. Melanoma can lie dormant for years before it resurfaces in places like lymph nodes, which is where my father's recurred. A small, seemingly innocuous lump on his groin.
My father was a doctor himself--an ophthalmologist--so he knew that his prognosis would not be good. And it wasn't; it was of the "get-your-affairs-in-order" variety. But, being a stubborn man, a first-generation Italian from Newark and the son of a steeplejack, Dr. Bill, as his patients called him, was just warming up. He had only begun preparing for what was going to be a grueling six-year run filled with fatigue, dehydration, pain and emotional exhaustion.
There were runner's highs, like when a limb perfusion appeared to work, followed by extreme lows, when the brain mets appeared. And then there were the second, third and fourth winds when promising new studies came out. On he went, plodding from surgery to chemo to radiation. From clinical trial to clinical trial. Along the course, family and friend had lined up to cheer him on, give him water and food or tend to his injuries. In June 2006, my father hit the wall. His melanoma could no longer be controlled. He was spent, and he wanted to enjoy the final leg of the race at a slow amble, absorbing the sights and sounds of the course and the gathering crowd. On November 11, 2006, he crossed the finish line at peace--surrounded by his biggest fans.
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BY ELIZABETH WHITTINGTON | FEBRUARY 9, 2012
Margaret Hamburg, MD, the Commissioner of the FDA released the statement below marking the 50 years from when thalidomide became a headline in the U.S. It's an interesting history lesson, although I'm a little disappointed she didn't mention that thalidomide later became a treatment (and springboard for other treatments) for myeloma - which is much more common than leprosy.
I also want to draw your attention to one of her closing statements:
Going forward, smart regulation requires regulatory flexibility that responds to changing situations, new information and new challenges. It also demands that we advance regulatory science: the knowledge and tools necessary for the meaningful and timely review of products for safety, efficacy, quality and performance.
The FDA has made some decisions lately that does require flexibility, including the Avastin decision in metastatic breast cancer. There have been some bumps along the way for sure, but as long as the agency remains flexible and allows itself to evolve with science and the increasingly loud voice of the public, it will be interesting to see where this takes us.
It's also worth noting that the agency approved several notable cancer treatments in 2011. And we're well on our way in 2012, as a few new treatments have already been approved this year ahead a schedule. Here's hoping for promising treatments and even some cures.
50 Years after Thalidomide: Why Regulation Matters
Posted on February 7, 2012 by FDA Voice
By: Margaret Hamburg, M.D.
Fifty years ago, the vigilance of FDA medical officer Dr. Frances Kelsey prevented a public health tragedy of enormous proportion by ensuring that the sedative thalidomide was never approved in the United States. As many remember, in the early 1960's, reports were coming in from around the world of countless women who were giving birth to children with extremely deformed limbs and other severe birth defects. They had taken thalidomide. Although it was being used in many countries, Dr. Kelsey discovered that it hadn't even been tested on pregnant animals.
Dr. Kelsey's reaction to thalidomide exemplifies the FDA's mission: protecting and promoting the health of the American people, using science for regulatory decision-making.
Now I know that in some circles regulation is viewed as a roadblock to innovation and economic growth. But in actuality, when done right, regulation isn't a roadblock; it's the actual pathway to achieving real and lasting innovation.
Smart, science-based regulation instills consumer confidence in products and treatments. It levels the playing field for businesses. It decreases the threat of litigation. It prevents recalls that threaten industry reputation and consumer trust, not to mention levying huge preventable costs on individual companies and entire industries. And it spurs industry to excellence.
The tragedy of thalidomide led to changes that strengthened both the regulatory and scientific environment for medical product development and review.
In response to the public uproar, in 1962 Congress enacted the Kefauver-Harris amendments to the Federal Food, Drug and Cosmetic Act. Thanks to these new amendments, manufacturers had to prove that a drug was not only safe, but also effective. Approvals had to be based on sound science. Companies had to monitor safety reports that emerged postmarket and adhere to good manufacturing practices that would lead to consistently safe products. And there were new protections for patients.
The amendments not only benefited patients, they helped industry, raising scientific standards that eventually ushered in today's sophisticated, science-based life sciences industry.
For the very first time, many companies put in place research and development programs, including the design and implementation of controlled clinical trials. Major therapeutic breakthroughs resulted, including the use of beta blockers in patients after a heart attack and angiotensin-converting enzyme inhibiters to improve survival in patients with heart failure. All of these were good news for public health and for corporate bottom lines. The best drugs and treatments rose to the top, not simply those that were most heavily marketed.
The Harris-Kefauver Amendments created a culture of quality and innovation that laid the foundation for our current regulatory environment which fosters a domestic pharmaceutical industry that is second to none.
Going forward, smart regulation requires regulatory flexibility that responds to changing situations, new information and new challenges. It also demands that we advance regulatory science: the knowledge and tools necessary for the meaningful and timely review of products for safety, efficacy, quality and performance.
Thalidomide, once again, is a good example. It came back on the U.S. market in 1998 after data showed it was safe and effective to treat a complication of leprosy. In an appropriate balancing of benefit and risk, FDA required strong safety monitoring and a strict dispensing plan before approving the drug.
Regulation such as this requires a strong, robust FDA, one endowed with the necessary resources to ensure smart, sound, science-based regulation.
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BY KATHY LATOUR | FEBRUARY 3, 2012
First a recap. For the past four days we have been bombarded with information about the decision by Susan G. Komen for the Cure to remove funding from 18 Planned Parenthood sites, using the reasoning that they don't fund any organization under investigation. Well, within about 12hours it became clear that the decision came straight from the office of Karen Handel the new Komen Vice President of Policy and a former Georgia office holder and gubernatorial candidate who is anti-abortion and has even gone so far as to say she is anti-Planned Parenthood.
Now there is enough evidence to confirm that the decision to stop funding organizations under investigation was made in December specifically to stop funding Planned Parenthood, and again it was Handel that drove the decision. Komen has been down the Planned Parenthood path a number of times in the past decade and had made what everyone thought was a final decision–-it would be funded. But that was before someone recommended Karen Handel as the best person for the job of Vice President of Policy.
That person is known in the ranks of Komen as someone who mixes a particularly powerful batch of Kool-Aid that Nancy Brinker has become addicted to.
So where are we? Komen stands by its decision, but now Nancy Brinker goes on television to say it's a policy change to give money to direct service organizations, not pass through groups, which means they want to give the money to the groups that do the mammograms and Planned Parenthood evidently doesn't do that, they must send women out and then pay for it from Komen funds. So why the switch?
Personally, I think Nancy considered what their decision would mean for poor women in Dallas who go to Parkland Hospital, which, I am fairly sure gets Komen funds for its screening program and has been under investigation for two years – and found guilty, by the way, in areas that don't pertain to screening. And no one thought about this before? Komen is in a mess and this is where the broken hearts come in.
At the first headline, I blew it off. Komen has been a target before, a lot. They are big, they raise a lot of money, and the well over 100 affiliates raise money through the Race for the Cure, 75 percent of which is kept local for their own screening, education and treatment needs. This money reaches the very poorest of the poor and the women who work tirelessly for Komen affiliates make a real and tangible difference in the lives of these women. These are the salt of the earth of the American heartland where women are proud to take care of each other and dedicate thousands of hours a year to do just that.
Speaking around the country at Komen events, I have met hundreds of Komen volunteers and I would be proud to call any of them a friend. I have never asked anyone if she was a Democrat or Republican or if she was for or against abortion.
With the 25 percent the national foundation receives they fund numerous other projects including basic research, and as a 25-year and 7-year survivor, and a woman who lost her mother to breast cancer, I count on research to be sure my daughter doesn't have to face this disease, and if she does, she lives through it.
I have been president of the board of two nonprofits funded by Komen, one, the Bridge Network, provides direct support to women diagnosed with breast cancer who have no insurance. The other was Gilda's Club North Texas, now Cancer Support Community. These programs would have had a much harder time without Komen.
But what has really broken my heart this week is talking to the women who built the foundation, some of whom spent upwards of 20 years committed to this cause. The woman who created the policy office at Komen, a survivor herself, spent endless hours in the halls of Congress during her 10-year tenure, which ended in 2008. She worked both sides of the aisle to overcome any idea that Komen was politically driven. She also convinced the leaders of our country that this organization was about more than pink ribbons, it was about the power of the vote. She organized advocacy groups before we understood what advocacy was about. For 10 years she grew the office, only to watch the newest occupant, who has been with Komen nine months, bring it down in two days.
These were strong women who wouldn't take no for an answer, just the way Nancy Brinker wouldn't when she started the organization as a promise to her sister. There are some of the "old guard" left, women who took Komen to the heights in the nonprofit world to make it what it was on Monday of this week: An organization committed to ending breast cancer that was built on integrity and very decidedly non political – because breast cancer doesn't care what you believe, it is an equal opportunity killer. There is no place for politics at Komen.
There are many of us who fear that Komen will not be able to recover from this in part because of the way it has been handled. If I had been Karen Handel, I would have offered my resignation immediately, and I was hoping she would have the honor to do that. Then I saw the retweet she posted, "Just like pro-abortion group to turn cancer orgs decision into a political bomb to throw. Cry me a freaking river" and feared the worse. This woman has no grace, no courage and an ego that doesn't care if she brings down in nine months what it took others 30 years to build.
Resign Karen. You owe it to a lot of people.
1:27 p.m. Nancy Brinker has made a statement that includes the following
"We will continue to fund existing grants, including those of Planned Parenthood, and preserve their eligiblity to apply for future grants," Nancy G. Brinker, the agency's ambassador, said in a statement.
So Handel is still there and to shut down the firestorm, PP can apply. This does not mean they will be funded.
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BY LINDSAY RAY | JANUARY 31, 2012
Skin Cancer
Ahead of its March 8 deadline, the Food and Drug Administration (FDA) approved Erivedge (vismodegib, GDC-0449) on Jan. 30 for patients with locally advanced basal cell carcinoma (BCC) that can't be treated with surgery or radiation or who have metastatic BCC, making Erivdege the first drug approved by the FDA for metastatic BCC. In another first, Erivedge is the first drug approved that works by inhibiting the Hedgehog pathway, which is involved in controlling cancer cell division and active in most BCCs. The drug is a pill taken once a day.
BCC, along with squamous cell carcinoma, is a non-melanoma skin cancer and one of the most common types of skin cancer, with an estimated 3.5 million cases diagnosed each year. Advanced BCC is rare, however, and disfiguring, which is why the drug fills an unmet need in this patient population. Last April, we covered some of the research about Erivedge (then known as GDC-0449) and even the first patient to try the drug, which you can read about here.
The approval in based on a multicenter trial with 96 patients. Of those with metastatic BCC, 30 percent had partial tumor shrinkage, and of those with locally advanced BCC, 43 percent had partial or complete tumor shrinkage.
Side effects include nausea, fatigue, hair loss, diarrhea, changes in taste and weight loss. Some serious side effects may occur, so a boxed warning will be included on the drug alerting physicians to potential risk of death or birth defects for an unborn baby. Doctors are required to verify pregnancy status before starting treatment.
A month's supply should cost $7,500, and Genentech (the drug's manufacturer) estimates a treatment course will last 10 months, totaling $75,000. The Patient Action Network Foundation has announced they will now offer co-payment assistance up to $7,500 per year for out-of-pocket expenses. To see the eligibility guidelines and for more information about the program, visit the Patient Action Network Foundation.
This drug should be available in one to two weeks, per the manufacturer.
For more information about Erivedge, visit www.erivedge.com.
Kidney Cancer
Just a few days before, on Jan. 27, the FDA also approved Inlyta (axitinib) for patients with advanced renal cell carcinoma (kidney cancer) who haven't responded to previous treatment.
Inlyta targets the vascular endothelial growth factor (VEGF) pathway, which is important to the development of new blood vessels in tumors, which helps tumors grow. The approval follows a 723-patient trial in which patients on Inlyta had a median progression-free survival of 6.7 months compared with the 4.7 months on the standard treatment, Nexavar (sorafenib).
Inlyta is a pill taken twice daily and is expected to cost around $8,900 per month. Side effects include diarrhea, fatigue, high blood pressure, decreased appetite and nausea. Because it can cause high blood pressure, individuals with this condition should have it controlled before taking Inlyta. Also, sometimes serious bleeding problems can occur, so patients with untreated brain tumors or gastrointestinal bleeding should not take Inlyta.
For more details, visit www.inlyta.com.
Non-Hodgkin Lymphoma
Finally, pixantrone was pulled from the FDA approval pipeline earlier this week. In 2010, the FDA rejected the drug, but Cell Therapeutics (its manufacturer) appealed and resubmitted the drug for approval as a treatment for non-Hodgkin lymphoma patients who no longer responded to other therapies. An FDA advisory meeting was set for Feb. 9, with a possible approval in April, but the manufacturer pulled the application to allow the company more time to prepare for the review. It plans to resubmit later this year.
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