Second vaccine to prevent cervical cancer approved by FDA

BY ELIZABETH WHITTINGTON | OCTOBER 16, 2009

Today, Cervarix became the second cervical cancer vaccine approved in the U.S. The FDA decided the vaccine, which is administered in three injections for females age 10 to 25, was safe and effective. It is recommended women receive the vaccine before becoming sexually active, which can exposed them to human papillomavirus (HPV), a virus linked to cervical cancer and other diseases.

In clinical studies, Cervarix was found to be 93 percent effective in preventing pre-cancers associated with HPV types 16 and 18, which cause about 70-75 percent of cervical cancers. Cervarix may also protect against types 31 and 45, which account for another 10 percent.

Because there are more than 100 types of HPV--15 of which have been associated with cancer--the vaccine does not offer full protection from cervical cancer, and women vaccinated are recommended to continue cervical cancer screening.

In a phase II study in which more than 1,000 women age 15 to 25 were vaccinated with either three doses of Cervarix or placebo, the vaccine showed protection for more than five years and demonstrated 100 percent efficacy in precancers caused by types 16 and 18, as well as 68 percent efficacy against cervical precancerous lesions and 38 percent benefit against abnormal Pap tests, regardless of HPV type. Side effects reported in studies of the vaccine include pain, redness, and swelling at the site of the injection, as well as headache, fatigue, and weakness.

Cervarix has been playing a game of catch-up to to Gardasil, which was initially approved in 2006 for prevention of cervical cancer in females ages 9 to 26 and has also been approved for vulvar and vaginal cancers and genital warts. Gardasil's maker has filed for additional indications for boys ages 9 to 26, because the virus can also cause genital warts in males (as well as penile and anal cancers), and for women older than 26. And although the two vaccines both protect against cervical pre-cancers and cancers associated with HPV types 16 and 18, studies have shown Gardasil also protects against types 6 and 11.

It's not known whether competition between the two vaccines may help bring down costs. Merck's Gardasil typically runs about $360 for all three shots, but is usually covered by insurance, while GSK officials say pricing information for Cervarix will be released in the next week or so. But whether one is more effective than the other is not known. While one study has shown Cervarix produces a higher immune response against the virus than Gardasil, no head-to-head studies have been conducted.

Update: The FDA also announced today that the agency approved Gardasil for boys age 9 to 26 to prevent genital warts.

Should you be concerned about the H1N1 virus?

BY ELIZABETH WHITTINGTON | OCTOBER 9, 2009

The H1N1 virus, or swine flu, has steadily swept across the country, and is considered widespread in 27 U.S. states now (view the CDC's interactive map).

And while the virus has primarily stricken young adults, those individuals at high risk for flu complications, which include the elderly and immunocompromised patients, should still consider getting vaccinated.

I had a chance to talk with Dr. Michael Boeckh, a member of the Vaccine and Infectious Disease Institute at Fred Hutchinson Cancer Research Center, last week on how the flu may affect cancer patients and he provided some valuable insight.

Boeckh suggests that there are certain individuals who are recommended to get the vaccine--namely those actively receiving chemotherapy or who are taking immunosuppressive drugs after a stem cell transplantation. Patients in this category who contract the flu, he says, could potentially have their treatment delayed or have other complications. "They are actually in a pretty high tier," he says, along with young children, pregnant women, and individuals with asthma, HIV, diabetes, lung disease, and cardiovascular disease. However, he suggests that most patients, regardless of treatment, be vaccinated.

"Except those who are very close to transplantation, they should all be vaccinated," Boeckh says. And while patients who have undergone a stem cell transplant within the past six months should not get the vaccine, he says it's important that family members and caregivers be vaccinated to reduce transmission of the virus.

For longterm survivors, Boeckh recommends they talk with their physician. Although the virus is least likely to affect people over 65 years of age, survivors may have other underlying conditions that may favor vaccination that would put them in a high tier (including those conditions listed above).

It's also suggested that patients who may have low immunity due to chemotherapy or transplantation receive the inactivated vaccine shot over the nasal mist, which uses a mild, but live, form of the virus. Unfortunately, the first batch of vaccines to be distributed, which began yesterday, is the nasal mist version. The shot version is expected to be widely distributed by mid-month.

And don't forget about the seasonal flu, Boeckh cautions. Individuals should be vaccinated for both the swine flu and seasonal flu.

"This first week of October, the predominant strain circulating, by far, is the swine flu, but that may change at any time," he says. "There is no reason to believe the seasonal flu will not come up. Typically, it's not even here this early. It's just about to start in a normal year."

Tips from the CDC:

To avoid getting the H1N1 flu:

Wash your hands often with soap and water. If soap and water are not available, use an alcohol-based hand rub.

Avoid touching your eyes, nose, and mouth. Germs spread this way.

Try to avoid close contact with sick people.

Follow public health advice regarding school closures, avoiding crowds, and other measures to keep our distance from each other to lessen the spread of flu.

To avoid spreading the flu:

Stay home for at least 24 hours after your fever is gone except to get medical care or for other necessities. (Your fever should be gone without the use of a fever-reducing medicine.)

Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.

Ask about antiviral drugs, which can make illness milder and shorten the time you are sick. They may also prevent serious flu complications. Antiviral drugs are not sold over-the-counter and are different from antibiotics.

For treatment, antiviral drugs work best if started within the first two days of symptoms.

FDA advisory panel unanimously recommends new kidney cancer drug

BY ELIZABETH WHITTINGTON | OCTOBER 6, 2009

Update [Oct. 20]: Pazopanib gets FDA approval. Read more...

There is probably no other cancer that has seen such breakthroughs in the past five years than kidney cancer. Less than a decade ago, patients with advanced renal cell carcinoma were treated with biological therapies, including interferon and interleukin, with few results. But in the past five years, there have been five drugs approved for the cancer--Sutent, Nexavar, Avastin, Torisel, and Afinitor.

Yesterday, the Oncologic Drugs Advisory Committee, a panel that reports to the Food and Drug Administration on whether a cancer drug should be approved or not, unanimously gave its recommendation for pazopanib. The panel said the drug appeared to be effective and its side effects were no more severe than other recently approved kidney cancer drugs.

The drug may also be a better alternative to some patients unable to tolerate the side effects of pazopanib's competitors. While studies show that pazopanib had a lower risk of rash and fatigue than with other kidney cancer drugs, some patients did develop diarrhea, hypertension, and nausea. The risk of severe liver injury, although rare, has also been noted.

Pazopanib, recently given a brand name of Votrient, was highlighted at this year's American Society of Clinical Oncology annual meeting where a phase III study compared the drug to placebo. Results showed the median progression-free survival in all patients more than doubled from 4.2 months with placebo to 9.2 months on pazopanib. (Newly diagnosed patients had improved PFS from 2.8 months to 11.1 months, while patients with prior biological treatment improved from 4.2 months to 7.4 months on the drug.)

Because there are so many kidney cancer drugs on the market now, some question whether pazopanib should be approved based on a placebo study. A phase III trial looking at the drug versus Sutent--the standard treatment for advanced kidney cancer--in locally advanced or metastatic RCC is currently ongoing. ODAC recommended the study be completed and that side effects continue to be monitored.

However, patients may not need to wait until the study is completed. The FDA is expected to make a decision on whether to approve the drug later this month.

Pazopanib, like some of the other approved kidney cancer drugs, including Sutent, is an antiangiogenic. These drugs inhibit the growth of new blood vessels that feed the tumor by targeting the vascular endothelial growth factor receptor. Other kidney cancer drugs, including Afinitor, on the other hand, target a protein called mTOR.

Robert Figlin, MD, interim director of City of Hope Comprehensive Cancer Center in Duarte, California, and director of the center's kidney cancer program, told CURE earlier this year that, in addition to the recent kidney cancer drug approvals, there may still be more on the horizon.

"We are already embarking on next-generation drugs," he says, including pazopanib, and another angiogenesis inhibitor, axitinib. "Both of these may have more activity than our currently available drugs." They might also have a better side effect profile, he says. "That's what we're looking for--better tolerance and more effectiveness."

And the increase in the number of treatment options for kidney cancer patients has an added benefit.

"This is a waterfall time for patients," he says. "The challenges for both doctors and patients are now how to choose the proper drugs, in what sequence, and whether or not to use them in combination."

For more on kidney cancer advancements, read "Reining in Renal Cancer" from the Summer 2009 issue of CURE.

Rare lymphoma receives a much-needed drug approval

BY ELIZABETH WHITTINGTON | SEPTEMBER 28, 2009

Folotyn (pralatrexate), a drug which made waves after results of a phase II trial were revealed at last year's American Society of Hematology meeting, was granted accelerated approval for peripheral T-cell lymphoma on Friday. (You can read more about the PROPEL study from CURE's 2008 ASH coverage).

The approval is a first for PTCL, a rare and aggressive type of lymphoma that does not have many treatment options. The FDA based its decision on an improved overall response rate with the drug. While progression-free survival or overall survival (common endpoints in clinical trials) have not yet been demonstrated in a study, the improvement in response rate was enough for the FDA to give a green light to Folotyn because of PTCL's aggressive nature and lack of successful treatments. Additional studies of the drug will be ongoing to further assess clinical benefit.

The drug's manufacturer, Allos, has established a patient assistance program to help with reimbursement issues once the drug is available, which is projected to be early October. Patients can learn more about ASAP (Allos Support for Assisting Patients) by calling 877-272-7102 or visiting www.getASAPinfo.com.

Remembering Patrick Swayze

BY ELIZABETH WHITTINGTON | SEPTEMBER 16, 2009

The news of Patrick Swayze's death on Monday night was unexpected, but not shocking. Pancreatic cancer is such a horrible disease, with a five-year survival rate of only 5 percent. The fact that he was able to work throughout much of his treatment and lived for nearly two years after his diagnosis is a silver-lining to this sad ending.

Swayze's death will certainly put pancreatic cancer more on the public radar, something this rare, but deadly disease is often lacking--awareness and funding for research. The Pancreatic Action Network, the national non-profit organization dedicated to ending pancreatic cancer, noted that although more than 42,000 people will be diagnosed and more than 35,000 will die each year of the disease, it is still "the most under-funded among leading cancer killers with less than 2 percent of the National Cancer Institute's annual research budget--a figure far too low given the severity of the disease."

Swayze did much to raise awareness of the disease and fought for increased spending for cancer research. In February, he penned a piece in the Washington Post, "I'm Battling Cancer. How About Some Help, Congress?" where he made a case for increased cancer research funding for the National Institutes of Health as part of the economic stimulus package. And he appeared in the September 2008 TV event "Stand Up to Cancer," where he said: "I keep dreaming of a future, a future with a long and healthy life, a life not lived in the shadow of cancer, but in the light. ... I dream that the word `cure' will no longer be followed by the words 'it is impossible. ... The longer we do nothing, the more people will die.' "

Thank you, Patrick, for the memories and your legacy as a cancer survivor.

Another news headline touting a possible cure for cancer. Yawn.

BY ELIZABETH WHITTINGTON | SEPTEMBER 11, 2009

Breaking news this morning ... another headline with "cure" and "cancer."

With as much excitement as I could muster, I read the opening paragraph after first noting it was a press release passed along by a news agency. A company has developed a technology for killing cancer cells in the lab. No new drug, no clinical trial results, no drug approval. And no excitement or follow up by CURE.

Why?

Unfortunately, headlines and press releases like this come across our desks pretty frequently at CURE. We've become a little immune, you might say. Now, if that technology helped researchers develop a drug or treatment ... that could work against cancer cells ... in actual patients ... with tolerable side effects, then it's news to us. That's why CURE rarely reports on pre-clinical studies involving cancer cells or animals, even if the results seem miraculous. That's why we don't devote features to a new gene being discovered in a cancer cell line that could be targeted by an undeveloped, futuristic drug.

Anti-angiogenic drugs, such as Avastin and Nexavar, have been touted as breakthroughs because they target a specific pathway that tumors exploit to grow inside the body, and they have proven results against certain cancers--but no one would call them a "cure" for cancer, and they're not without their side effects. When the idea of angiogenesis was first realized in the 1960s by Judah Folkman, not many people took notice. Over several decades, drugs have been developed using this knowledge of angiogenesis, and large-scale trials have been conducted. Even Herceptin, another wonder drug, took decades and a few wrong turns to get from identifying a specific gene on a breast cancer cell to an approved drug that works in a minority of breast cancer patients (those with cancer that overexpress HER2).

Even when we do report on drugs that appear to work against a certain cancer in a clinical trial, later and larger trials may show the drug really doesn't benefit patients more than already approved drugs.

So, we can report on this new possibility of a cancer cure that--if it is that one in a million--may produce visible effects for patients in about 20 years ... if researchers work fast with few mistakes. And while drug development is speeding up (read our senior scientfic advisor Diane Gambill's blog on "PARP inhibitors prime example of acceleration in drug discovery"), it may take years for patients to reap the rewards of this new, possible cancer-curing technology.

So, CURE waits. We report on the breakthroughs and large-scale studies that excite oncologists who are in the field treating patients. We report on drug approvals that could affect thousands of patients the day a certain drug goes to market.

And if (or when) this new technology produces actual results for cancer patients, we'll make sure you know about it.

Tuning in for tonight's health care speech? Here are some interesting sites to help you prepare.

BY ELIZABETH WHITTINGTON | SEPTEMBER 9, 2009

I'll be the first to admit that I haven't exactly done all of my research with the health care reform debate; but let's face it, it's a pretty complicated issue.

In doing my cram session, however, I did come across a couple of interesting finds to take a look at before President Obama's health care speech to Congress tonight.

NPR's "What Health Care Overhaul Means For You" offers an easy way to see what the major health care proposals before Congress would mean for you.

The New York Times's "What to Watch For in Obama's Speech" asks some of the big questions that may be answered tonight, including will he continue to support a public option, how far will he go to achieve bi-partisan support, and how will centrist lawmakers react to the speech.

You can watch the speech tonight via streaming video at http://www.whitehouse.gov/live/ and also participate in a live discussion via Facebook while President Obama's gives his speech. (You will have to download an application.)

And Rodale, the publisher of several health magazines, including Prevention and Women's Health, will be streaming live commentary from its editors and several medical advisors during the address at Rodale.com.

And just in case you've been living on the moon for the past few days, President Obama's health care speech will begin at 8 p.m. Eastern tonight. I'll be very interested in not only President Obama's speech itself, but the reaction from lawmakers, the media, and the public.

Do you know any other interesting sites, articles, or interactive tools to look at before tonight?

Zevalin approved as first-line non-Hodgkin lymphoma therapy

BY ELIZABETH WHITTINGTON | SEPTEMBER 4, 2009

The approval of Zevalin (ibritumomab tiuxetan) as a first-line therapy for non-Hodgkin lymphoma was announced today. The drug was originally approved in 2002 for NHL patients whose cancer recurred or progressed after other therapies.

The new approval was based on a phase III study where patients whose cancer responded to first-line chemotherapy were given Zevalin. At 3.5 years follow-up, the group that received Zevalin as part of their first-line treatment had a significantly better median progression-free survival time than the control group (38 months compared to 18 months).

An antibody that contains a radioactive molecule, Zevalin works by delivering a lethal dose of DNA-damaging radiation to tumor cells. However, many NHL patients are only offered the drug as a last resort.

Bruce Cheson, MD, head of hematology and director of hematology research at Lombardi Comprehensive Cancer Center at Georgetown University, told CURE earlier this year that radioactive drugs, such as Zevalin and a similar drug, Bexxar (tositumomab), are some of the most effective NHL therapies on the market, but are also some of the least used. They are expensive (costing about $25,000 per treatment) and must be administered in a hospital under the supervision of a radiologist because of the drugs' radioactivity.

I'm not sure how Zevalin's most recent approval will help tackle the issue of cost and availability, but at least the option is now there for newly diagnosed NHL patients. An announcement on the drug's recent approval issued by the drug's manufacturer, Spectrum, mentioned that the company has plans to overcome these issues, which have plagued Zevalin since its original approval.

You can read more about Zevalin--and view an illustration on how the drug works--in Trying Something New from CURE's Spring 2009 issue.