FDA: Gardasil approved to prevent anal cancer

The U.S. Food and Drug Administration today (December 22) approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.

Gardasil is already approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females. It is also approved for the prevention of genital warts caused by types 6 and 11 in both males and females.

“Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

Although anal cancer is uncommon in the general population, the incidence is increasing. HPV is associated with approximately 90 percent of anal cancer. The American Cancer Society estimates that about 5,300 people are diagnosed with anal cancer each year in the United States, with more women diagnosed than men.

Gardasil’s ability to prevent anal cancer and the associated precancerous lesions [anal intraepithelial neoplasia (AIN) grades 1, 2, and 3] caused by anal HPV-16/18 infection was studied in a randomized, controlled trial of men who self-identified as having sex with men (MSM). This population was studied because it has the highest incidence of anal cancer. At the end of the study period, Gardasil was shown to be 78 percent effective in the prevention of HPV 16- and 18-related AIN. Because anal cancer is the same disease in both males and females, the effectiveness data was used to support the indication in females as well.

Gardasil will not prevent the development of anal precancerous lesions associated with HPV infections already present at the time of vaccination. For all of the indications for use approved by the FDA, Gardasil's full potential for benefit is obtained by those who are vaccinated prior to becoming infected with the HPV strains contained in the vaccine.

Individuals recommended for anal cancer screening by their health care provider should not discontinue screening after receiving Gardasil.

As of May 31, 2010, more than 65 million doses of Gardasil had been distributed worldwide, since its approval in 2006 according to the manufacturer, Merck and Co. Inc, of Whitehouse Station, N.J. The most commonly reported adverse events include fainting, pain at the injection site, headache, nausea, and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries. This can be prevented by keeping the vaccinated person seated for up to 15 minutes after vaccination. This observation period is also recommended to watch for severe allergic reactions, which can occur after any immunization.

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FDA Approves First Maintenance Drug Therapy for Advanced Lung Cancer

The U.S. Food and Drug Administration has approved Alimta (pemetrexed), the first drug available for maintenance therapy of advanced or metastatic lung cancer.

Patients with cancer often receive maintenance therapy to prevent the disease from progressing after their tumor has shrunk or the disease has stabilized in response to chemotherapy. Alimta disrupts metabolic processes that are dependent on the B-vitamin folate, a necessary ingredient for cell replication.

“This drug represents a new approach in the treatment of advanced non-small cell lung cancer,” said Richard Pazdur, M.D., director, Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Typically, patients whose tumors respond to chemotherapy do not receive further treatment after four-to-six chemotherapy cycles. This study demonstrates an advantage in overall survival in certain patients who received Alimta for maintenance therapy.”

Non-small cell lung cancer has several subtypes, including squamous cell, large cell, adenocarcinoma and mixed histology cancers. In a 600-patient clinical trial, people with predominantly squamous cell cancer did not benefit from Alimta. But those with other subtypes of non-small lung cancer survived an average 15.5 months following treatment compared with 10.3 months for patients who received an inactive substance (placebo). All patients in the study received standard medical care.

Reported adverse events included damage to blood cells, fatigue, nausea, loss of appetite, tingling or numbness in the hands and feet, and skin rash.

Alimta initially was approved in 2004 for the treatment of patients with mesothelioma, a cancer frequently related to asbestos exposure. The drug was later approved for the treatment of patients with non-small cell lung cancer whose disease worsened on prior chemotherapy drugs and also as an initial therapy for advanced non-small cell lung cancer.

Alimta is manufactured by Eli Lilly & Co. of Indianapolis.

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Oncology Care Quality Improvement Program Introduced by Bipartisan Coalition Dedicated to Better Cancer Care Nationwide

/PRNewswire/ -- A bipartisan group of members from the U.S. House of Representatives introduced a bill late yesterday aimed at improving oncology care in the United States by refocusing efforts towards patient-centered cancer care delivery and studying the best methods to coordinate care and extend quality of life. The "Oncology Care Quality Improvement Program of 2009" will establish a voluntary pilot program to identify major areas of potential improvement to oncology care, including error reduction, increased patient education and care coordination, and expansion of end-of-life planning and counseling services.

This groundbreaking oncology legislation, led by U.S. Representative Joseph Crowley (NY-7), has 18 original cosponsors, including lead sponsors Reps. Mike Rogers (MI-08), Lois Capps (CA-23), Anna Eshoo (CA-14) and Paul Ryan (WI-01). The bill has been endorsed by National Patient Advocate Foundation (NPAF), US Oncology, Society of Gynecologic Oncologists (SGO), Association of Community Cancer Centers (ACCC) and UPMC Cancer Centers.

"Fighting cancer is a fight we must win," said Rep. Joseph Crowley (NY-7). "This innovative demonstration project will ensure that patients and doctors have the best tools and information at their disposal. By providing our health care providers with most-up-to date information on best practices, we will ensure cancer patients are given the best and most cost-effective care. I thank Rep. Rogers, Capps, Eshoo and Ryan and colleagues from both sides of the aisle for joining me in leading this fight for oncology patients, doctors and families. We are proud to have the endorsement of the National Patient Advocate Foundation and US Oncology, our partners in working to get this program enacted swiftly."

"Cancer is one of the great health care challenges of our time," said Rep. Mike Rogers (MI-08). "Half of all men and one third of women will be diagnosed with cancer at some point in their lives and these figures are expected to skyrocket as the Baby Boom generation ages. That's why I'm proud to join Rep. Crowley to introduce this legislation, which will improve the quality of care for seniors with cancer while also creating a more efficient Medicare system."

"As researchers and clinicians work to improve cancer care in innovative ways, I'm proud to be part of this effort by Congress and CMS to evaluate the innovative use of health information technology in order to improve cancer care overall," said Rep. Lois Capps (CA-23). "The standard for oncology care in the 21st Century is about comprehensive care planning and coordination. By providing incentives to use the newest health information technology tools available, we can assist providers and patients in achieving optimal information sharing on best practices and better coordination among clinicians."

"As we begin to work on health care reform in the House, it's more important than ever that we look at every option available to help increase the quality of care while decreasing the overall cost of health care," said Rep. Anna Eshoo (CA-14). "This pilot program gives participating oncology groups the flexibility and incentives necessary to explore cost-saving measures without sacrificing the quality care their patients receive."

"Like most Americans, my family has been personally touched by cancer and personally motivated in our fight against cancer," said Rep. Paul Ryan (WI-01). "I remain committed to doing all that I can to find a cure for this disease, while working to promote innovate and compassionate improvements to oncology care. I am a proud to help introduce the Oncology Care Quality Improvement Program, and thank Rep. Crowley and my colleagues on both sides of the aisle for working on this important piece of legislation and for their leadership in the fight against cancer."

"Finally, we have a thoughtful, progressive, quality-driven program that achieves patient-centric cancer care delivery, while reducing costs at the same time. It is a win for the patient, the taxpayer and the physician," said Dr. Roy Beveridge, Chief Medical Officer, US Oncology.

National Patient Advocate Foundation (NPAF) continued, "NPAF is pleased to offer its strong support for the Oncology Care Quality Improvement Program of 2009. This legislation calls for adherence to evidence-based guidelines which will reduce variation in care for patients and help physicians make clinical decisions with evidence of proven treatment regimens. In addition, NPAF commends Rep. Crowley for addressing the importance of an adequate medical workforce as well as appropriate reimbursement which are critical in order for education and care coordination to have a meaningful impact on patients and our health care system."

Background on the Oncology Care Quality Improvement Program of 2009:

The oncology care quality improvement (OCQI) program is a cost-saving, voluntary pilot program, to be led by the Centers for Medicare and Medicaid Services (CMS) in consultation with an advisory committee of expert oncology community physician, nurse, patient organizations and industry leaders. The OCQI will evaluate the impact of provider-led approaches to improve care quality and outcomes for Medicare beneficiaries with cancer while creating greater care efficiencies to reduce costs. The OCQI aims to foster evidence-based guideline adherence to minimize variation and reduce errors in care, offers patient education and care coordination services to help patients avoid and/or address common effects of their cancers and treatments, and provides end-of-life planning and counseling services that aims to improve quality of life.

The OCQI will provide payments to participating oncology groups - based on their meeting of defined performance goals as well as per capita expenditure targets created by CMS - to be allocated from half of the program savings generated by the participating group. The other half of the program savings will be retained by the Medicare program.

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FDA Approves Drug for an Advanced Form of Kidney Cancer

The U.S. Food and Drug Administration today approved Afinitor oral tablets (everolimus) for the treatment of patients with advanced kidney cancer whose disease has progressed after treatment with other cancer therapies.

Renal cell cancer, the most common type of kidney cancer, originates in the lining of the small tubules in the kidney that filter waste products from the blood. The cancer is resistant to such standard treatments as radiation therapy and chemotherapy, and the initial treatment for most patients is surgical removal of the kidney. If the cancer is confined to the kidney, the five-year survival rate is 60 to 70 percent; but the survival rate is considerably lower after the cancer has spread to other parts of the body.

"Afinitor provides an option for patients with advanced renal cell cancer after failure of treatment with the cancer therapies sunitinib or sorafenib," said Robert Justice, M.D., director, Division of Drug Oncology Products in the FDA's Center for Drug Evaluation and Research. "Targeted cancer therapies like Afinitor have increased the number of months patients can live without the tumor progressing."

Afinitor belongs to a class of drugs called kinase inhibitors, which interfere with cell communication, preventing tumor growth. The drug is intended for those patients with advanced renal cell cancer who have already tried another kinase inhibitor, Sutent (sunitinib) or Nexavar (sorafenib).

While Sutent and Nexavar are multiple kinase inhibitors (acting on a number of cellular targets), Afinitor works by blocking a specific protein known as the mammalian target of rapamycin or mTOR. The protein blocking action disrupts the growth, division and metabolism of cancer cells.

A clinical trial studying the safety and effectiveness of Afinitor was discontinued after an interim analysis showed that, in patients receiving the drug, the growth or spread of the tumor was delayed when compared to patients who did not receive the drug. In addition, disease progression was delayed approximately five months in half of the patients who received Afinitor. In contrast, disease progression was delayed two months in patients who did not receive the drug.

The most frequent adverse reactions in the trial (occurring in at least 20 percent of patients) included inflammation in the mouth, loss of strength, diarrhea, poor appetite, fluid buildup in the extremities, shortness of breath, coughing, nausea, vomiting, rash, and fever. Laboratory tests of blood samples determined that at least half of all patients experienced anemia, low white blood counts, high cholesterol and high triglycerides and high blood sugar.

Afinitor is manufactured by Novartis International AG of Basel, Switzerland. Sutent is manufactured by Pfizer Inc. of New York. Nexavar is manufactured by Bayer HealthCare AG, Leverkusen, Germany.

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