Food and Drug Administration – Page 5

Males can get HPV vaccine Gardasil thanks, in part, to Gulfport cancer survivor

Source: St. Petersburg Times Author: John Barry David Hastings' crusade to inoculate boys against a cancer-causing virus that afflicts women — but threatened him, too — has scored a victory. But it's not quite the one he has been fighting for in the past three years. A panel of the Centers for Disease Control and Prevention last week allowed a vaccine to be given to boys and young men that is already used to protect girls and young women from human papillomavirus, HPV, which causes cervical cancer. The panel's vote followed the Food and Drug Administration's recent okay of the vaccine for boys as a protection against genital warts. The vaccine, Gardasil, was approved only for females, ages 9 to 26, in 2006. But research has since linked HPV to many oral cancers in men. Hastings, who owns the Habana Cafe in Gulfport with his wife, Josefa, testified before the CDC's Advisory Committee on Immunization Practices. He told them how HPV was found in a deadly carcinoma in his throat in 2006. It took seven weeks of simultaneous chemotherapy and radiation at the H. Lee Moffitt Cancer Center in Tampa to arrest the cancer. Ever since, he has spread the message that HPV is a threat to men. He urged the CDC panel to recommend routine vaccinations for boys, as it already does for girls. Hastings and other proponents argued that only 17 percent of girls are completing the series of three doses needed for protection. "We rely on females [...]

Charlotte Parker2009-10-30T10:58:18-07:00October, 2009|Oral Cancer News|

Lilly Erbitux cancer drug not worth price, U.S. scientists say

Source: www.bloomberg.com Author: Lisa Rapaport Eli Lilly & Co.’s tumor-fighter Erbitux doesn’t prolong lung cancer patients’ lives enough to justify its $80,000 cost, U.S. scientists said in commentary published today. Erbitux added to other cancer drugs extends survival about 1.2 months more than chemotherapy alone, making the price too high for a “marginal benefit,” commentary in the Journal of the National Cancer Institute said. Erbitux, which Lilly markets with Bristol-Myers Squibb Co., generated $1.3 billion last year as treatment approved for other malignancies. The high price of some of the newest cancer medicines are coming under scrutiny as part of an effort by lawmakers and health officials to rein in overall medical costs. President Barack Obama has set aside $1.1 billion in the U.S. economic stimulus bill to study the comparative effectiveness of treatments for cancer and other diseases. “We must avoid the temptation to tell a patient that a new drug is available if there is little evidence that it will work better than established drugs that could be offered at a miniscule fraction of the cost,” wrote the commentators, Tito Fojo with the National Cancer Institute and Christine Grady at the National Institutes of Health. Lilly, of Indianapolis, and marketing partner Bristol- Myers, of New York, withdrew an application to extend the Erbitux’s use to lung tumors in February after the Food and Drug Administration questioned differences in American and European versions of the treatment. $10,000 a Month The authors projected that Erbitux costs $80,000 based on a [...]

Oral Cancer Foundation News Team - A2009-09-27T11:35:34-07:00September, 2009|Oral Cancer News|

Where cancer progress is rare, one man says no

Source: nytimes.com Author: Gardiner Harris Politicians and researchers have predicted for nearly four decades that a cure for cancer is near, but cancer death rates have hardly budged and most new cancer drugs cost a fortune while giving patients few, if any, added weeks of life. For this collective failure, the man atop the nation’s regulatory agency for new cancer drugs increasingly — and supporters say unfairly — gets the blame: Dr. Richard Pazdur. Patient advocates have called Dr. Pazdur, director of the Food and Drug Administration’s cancer drug office, a murderer, conservative pundits have vilified him as an obstructionist bureaucrat, and guards are now posted at the agency’s public cancer advisory meetings to protect him and other committee members. “The industry is not producing that many good drugs, so now they’re looking for scapegoats in Rick Pazdur and the F.D.A.,” said Ira S. Loss, who follows the drug industry for Washington Analysis, a service for investors. In 10 years at the Food and Drug Administration, Dr. Pazdur, 57, has helped to loosen approval standards for cancer medicines and made it easier for dying patients to get experimental drugs. But he demands that drug makers prove with near certainty that their products are beneficial, a requirement that he repeated at a public advisory hearing on Sept. 1 in the slow, loud tones of someone disciplining a dog. After he spoke, the committee of experts voted to reject both drugs. Critics say that Dr. Pazdur’s resolve has cost thousands of lives [...]

Oral Cancer Foundation News Team - A2009-09-16T05:02:16-07:00September, 2009|Oral Cancer News|

BioVex agrees SPA with the FDA for a pivotal phase III study with OncoVEX (GM-CSF) in head and neck cancer

Source: news.prnewswire.com Author: press release BioVex Inc, a biotechnology company developing clinical stage treatments for cancer and the prevention of infectious disease, announced today that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase III clinical trial evaluating its lead product, OncoVEX (GM-CSF), for the first-line treatment of patients with squamous cell cancer of the head and neck. The study is the second the Company has agreed with the FDA under the Special Protocol Assessment (SPA) procedure and highlights the broad potential utility of BioVex's first-in-class cancer destroying virus technology. The first SPA was in melanoma under which BioVex is currently conducting a pivotal Phase III trial. Patients with head and neck cancer often present with locally advanced, bulky disease that is too large, or too close, to vital organs to remove surgically. These patients typically undergo combination radiation and chemotherapy treatment, in some cases with additional surgery. Patients who present with tumor-containing lymph nodes are particularly difficult to treat and approximately half of these patients relapse within two years. Philip Astley-Sparke, President & CEO, for BioVex said: "The announcement of our second SPA governing a Phase III study demonstrates the breadth of the commercial opportunity with OncoVEX . In addition to treating metastatic disease as is the intention in our ongoing Phase 3 study in melanoma, following multiple systemic responses in Phase II, OncoVEX also has considerable potential utility in treating discrete solid tumor masses across multiple indications including those that are [...]

Oral Cancer Foundation News Team - A2009-09-15T14:20:04-07:00September, 2009|Oral Cancer News|

Particle beam radiation therapy promising but unproven for treating cancer

Source: www.reuters.com Author: Particle beam radiation therapy, a technology used to treat several types of cancer, is considered by some clinicians to be better than traditional radiation, but there is limited evidence about its safety compared with other types of radiation therapy, according to a new comparative effectiveness report funded by HHS' Agency for Healthcare Research and Quality. "As technologies develop and new clinical interventions arise, it is important to balance access to potentially beneficial new technologies with ongoing research and evaluation to determine whether the technologies deliver what they promise," said AHRQ Director Carolyn M. Clancy, M.D. "Increased funding for comparative effectiveness research is an exciting opportunity to continue important research on medical therapies and interventions." Particle beam radiation therapy -- also known as charged particle radiation therapy or proton beam radiation therapy -- uses beams of protons or other charged particles for cancer radiation treatment. Particle beam radiation therapy is an alternative to other types of cancer radiation therapy such as external radiotherapy with ionizing photon (X- or gamma-ray) beams or brachytherapy with implanted radioactive sources. All types of radiation therapy can harm both cancerous and healthy tissues, so clinicians strive to target the radiation to the cancer while avoiding adjacent healthy tissues. This is particularly important for tumors adjacent to critical body parts such as those in the eye, brain, head and neck. Particle beam radiation therapy can target the radiation with a high degree of precision, but its potential advantages over other radiotherapy alternatives have not [...]

Oral Cancer Foundation News Team - A2009-09-10T07:42:42-07:00September, 2009|Oral Cancer News|

FDA Advisory Committee recommends approval for use of GARDASIL® in boys and men

Source: www.merck.com Author: press release Merck & Co., Inc. announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee agreed that efficacy, immunogenicity and safety data from clinical trials in males support the use of GARDASIL¨ [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11. "Merck has been committed to pursuing the use of GARDASIL in both males and females since the vaccine was discovered over a decade ago," said Peter S. Kim, Ph.D., executive vice president, and president of Merck Research Laboratories. "We are pleased that the Advisory Committee agrees that the data support the use of GARDASIL in boys and men.” The committee’s recommendation will be considered by the FDA in its review of the supplemental Biologics License Application (sBLA) that Merck submitted for GARDASIL in December 2008. The FDA is not bound by the committee’s guidance, but takes its advice into consideration when reviewing vaccines. Merck expects a decision from the FDA in the fourth quarter of 2009 after the agency has completed its review of Merck's application. “Today's discussion with the Advisory Committee brings the public health community closer to being able to provide GARDASIL to both men and women," said Anna R. Giuliano, Ph.D., Moffitt Cancer Center. GARDASIL has been approved for use in the U.S. since June 2006 and is [...]

Oral Cancer Foundation News Team - A2009-09-09T21:02:25-07:00September, 2009|Oral Cancer News|

Tobacco giants challenge law

Source: online.wsj.com Author: David Kesmodel, Lauren Etter & Alicia Mundy Reynolds American Inc., Lorillard Inc. and several other tobacco companies filed a lawsuit Monday seeking to block various provisions of a new federal tobacco law on the grounds that the provisions violate the companies' First Amendment rights. The tobacco companies said the recently enacted law, which placed the industry under the oversight of the Food and Drug Administration, sharply restricts the companies' right to advertise their products to adult tobacco users. The companies object to such provisions as a requirement that cigarette makers expand the size of warning labels so that they cover the top half of the front and back of cigarette packs, and include graphic images such as diseased lungs. This change, they say, would leave manufacturers with only a small and often-obscured portion of a cigarette pack to print their own messages. The companies also challenged a rule that restricts their ability to publicize the relative health risks of certain products such as smokeless tobacco. The suit was filed against the FDA in a federal district court in Bowling Green, Ky., the home of one of the plaintiffs, Commonwealth Brands Inc. An FDA spokeswoman said the agency doesn't comment on lawsuits. The FDA recently announced that its choice for its "tobacco czar" to run the new tobacco regulation center is Lawrence Deyton, who led antismoking efforts at the Department of Veterans Affairs. Many of the FDA regulations won't take effect until next year and the years that [...]

Oral Cancer Foundation News Team - A2009-09-01T12:13:33-07:00September, 2009|Oral Cancer News|

Cervical cancer vaccine Gardasil still faces questions

Source: www.philly.com Author: Marie McCullough Three years after the world's first cervical-cancer vaccine was hailed as a public-health breakthrough, Gardasil is facing renewed questions about its safety and value. In today's Journal of the American Medical Association, federal researchers analyze 12,424 voluntary reports of post-vaccination "adverse events" ranging from headaches to deaths. They conclude that only two complaints - fainting and dangerous blood clots -- are more common than expected and may be related to the immunization. But an accompanying editorial points out that many questions about Gardasil remain - key among them, whether it really will reduce the toll of cervical cancer. Another opinion piece in JAMA looks at Merck & Co.'s marketing strategy, contending the company coopted professional medical societies to promote and recommend the vaccine. Merck - already on the defensive over Gardasil's second-quarter sales, which slumped sharply in the United States and worldwide - said in a statement that "we welcome continued study and discussion" of the product's safety. "The bottom line is that Gardasil has a very positive benefit-risk profile," Richard M. Haupt, head of Merck's clinical program for the vaccine, said in an interview. Gardasil, a series of three shots, protects against two strains of the sexually transmitted human papillomavirus (HPV) that cause 70 percent of cervical-cancer cases. Gardasil also wards off two other HPV strains that cause 90 percent of genital warts in men and women. Next month, advisers to the Food and Drug Administration will consider whether to recommend expanding Gardasil's current [...]

Oral Cancer Foundation News Team - A2009-08-19T06:37:56-07:00August, 2009|Oral Cancer News|

Packing a heavier warning

Source: www.washingtonpost.com Author: Ranit Mishori Coming soon to the lives of American smokers: cigarette labels that go far beyond a simple warning. Imagine gruesome color photographs showing a mouth riddled with cancer, lungs blackened, a foot rotten with gangrene. If the images sound sickening, well, that's the point. Under a law signed by President Obama on June 22 -- the Family Smoking Prevention and Tobacco Control Act -- tobacco companies will be required to cover 50 percent of the front and rear panels of cigarette packages with color graphics showing what happens when you smoke and bold, specific labels saying such things as: "WARNING: Cigarettes cause fatal lung disease." "WARNING: Tobacco smoke can harm your children." "WARNING: Smoking can kill you." The first U.S.-mandated label in 1965 tentatively suggested "Cigarette Smoking May Be Hazardous to Your Health." Although the language changed over time, critics have long dismissed U.S. labeling as anemic and ineffective. Indeed, the inspiration for the new labeling standards comes from abroad. Canada started the trend in 2000 with a label that showed a picture of mouth cancer. "It's the one that smokers remember more than anything else. Even after nine years," says David Hammond, a researcher from the Department of Health Studies at the University of Waterloo in Ontario. Since then, he says, more than two dozen countries have picked up on the idea. A sampling of how explicit the labels can be: Malaysia's cigarette packs bear a photo of a diseased lung; some in Brazil show [...]

Oral Cancer Foundation News Team - A2009-08-05T04:48:03-07:00August, 2009|Oral Cancer News|

Genmab says FDA lifts hold on zalutumumab studies

Source: www.reuters.com Author: staff Danish biotechnology firm Genmab said on Thursday: - The U.S. Food and Drug Administration lifted a partial clinical hold on zalutumumab studies being conducted under a U.S. Investigational New Drug application. - Enrolment of patients can now resume in the Phase II study in patients with head and neck cancer considered incurable with standard treatment and the Phase I/II frontline study of zalutumumab in combination with chemo-radiation. Note: 1. Reporting by Copenhagen newsroom

Oral Cancer Foundation News Team - A2009-07-16T12:08:09-07:00July, 2009|Oral Cancer News|