FDA – Oral Cancer News

Viome scores FDA breakthrough label for cancer-screening, microbiome-sequencing AI platform

Source: www.fiercebiotech.com Author: Andrea Park The secret to enabling early cancer detection could be hidden in the microbiome, and, now, gut-testing startup Viome has the backing of the FDA to prove it. Viome was initially launched as a direct-to-consumer service that used an artificial intelligence-powered platform to sequence the RNA in an individual’s stool sample to produce insights into their overall health and provide accompanying diet and lifestyle recommendations. More recently, however, the startup has set its sights on using the technology to screen for cancer. In a study published last August, Viome researchers used the platform to analyze saliva samples from oral cancer patients and discovered biomarkers in the resulting analysis that were directly linked to cancer signatures. The diagnostic was able to spot early signs of oral cancer with a sensitivity of about 83%—and over 93% for stage 1 cancers—and a specificity of nearly 98%. As a result of that and other ongoing research, Viome’s saliva test has received the FDA’s breakthrough device designation for use in early screening for oral squamous cell carcinoma and oropharyngeal cancer, both of which are typically only diagnosed in a manual examination and are therefore often overlooked until their later stages. “Today’s standard of care to detect oral and throat cancer is severely outdated. Everyone relies on a primary care clinician to examine their mouths and look for lesions. This subjective and qualitative approach is a key reason why oral and throat cancer are detected at stage three or four, when many [...]

Oral Cancer Foundation News Team - A2022-07-13T06:40:29-07:00July, 2022|Oral Cancer News|

New saliva oral and throat cancer diagnosis test receives FDA approval

Source: medicalxpress.com Author: Rose Trapnell, Queensland University of Technology A QUT researcher's identification of saliva as an early detection liquid biopsy for oral and throat cancer has been realized by the development and commercialization of a diagnostic device by US-based biotech company Viome. Viome's early detection device has been designated a Breakthrough Device by The Food and Drug Administration (FDA) in the US. QUT Associate Professor Chamindie Punyadeera has spent a decade researching the possibility of saliva being the optimum diagnostic liquid for the early detection of oral and throat cancer. Professor Punyadeera was driven to this field of research after her young brother-in-law passed away within six months of being diagnosed with oral cancer. Her systematic collection of saliva samples from oral and throat cancer patients, establishment of saliva collection and optimisation protocols, identification of a key unmet-clinical need and work with clinicians provided the foundations for the commercialisation of the new device. "This test could save many lives because until now early-stage oral cancer has been hard to detect because effective diagnostic tools have not been available," Professor Punyadeera said. "This has led to late diagnosis, a poor prognosis and low survival rates." Professor Punyadeera said the risk of oral cancer increased with age and increased more rapidly after the age of 50. "The salivary metatranscriptome as an accurate diagnostic indicator of oral cancer" has been accepted for publication in npj Genomic Medicine.

Oral Cancer Foundation News Team - A2021-05-08T06:16:26-07:00May, 2021|Oral Cancer News|

FDA approves Gardasil 9, the HPV vaccine, to prevent head-and-neck cancer

Source: www.statnews.com Author: Matthew Herper For the past decade, evidence has suggested that Gardasil, the HPV vaccine, could stem an epidemic of throat cancer. But it has also never received approval from the Food and Drug Administration for that use — and it was unclear if it ever would. Charles Rex Arbogast/AP On Friday, the agency granted that approval, clearing the latest version of the vaccine, Gardasil 9, to prevent a cancer that affects 13,500 Americans annually. The decision was announced by Gardasil’s maker, Merck. The decision doesn’t change recommendations about who should get the vaccine, which is already recommended for females and males ages 9 through 45 to prevent cervical, vulvar, vaginal, and anal cancer as well as genital warts. But cancers of the head and neck — mainly those of the tonsils and throat — have been left off the list. It’s a striking omission, because head and neck cancer, mostly cancer of the throat, is the most common malignancy caused by HPV, the human papilloma virus, in the U.S. According to the Centers for Disease Control and Prevention, there are 35,000 cases of HPV-related cancer in the U.S. annually. On top of the 13,500 cases in the throat, 10,900 are cases of cervical cancer. “That’s excellent news,” said Stewart Lyman, a pharmaceutical consultant whose doctors discovered a tumor in his throat in 2016. It was removed surgically, and was caused by HPV. “To have this extended to head and neck cancer is really very helpful [...]

Oral Cancer Foundation News Team - A2020-06-13T05:42:56-07:00June, 2020|Oral Cancer News|

AN E-CIGARETTE COMPANY PUT VIAGRA AND CIALIS IN ITS VAPING LIQUIDS, AND THE FDA IS NOT PLEASED

Source: newsweek.com Date: 10/13/18 Author: Kelly Wynne A vape company, HelloCig Electronic Technology Co., has included Viagra and Cialis in its liquids, and has raised the ire of the Food and Drug Administration. One liquid was called e-Cialis, a popular erectile dysfunction drug, and was displayed with photos of the real product, according to Ars Technica. A weight loss drug, whose brand was banned in Europe, was allegedly adapted into the liquid form as well, though FDA testing proved it instead contained the erectile dysfunction medication found in Viagra. The FDA sent a warning letter to HelloCig on Thursday. It urged the company to make the necessary changes to properly market their products and asked they comply with FDA regulations to continue selling any type of drug. HelloCig alleged they responded to the FDA in a statement sent to USA Today Saturday. “Our aim is to fully comply with all FDA regulations, both in letter and spirit," the statement read. The FDA also released a statement, written by FDA Commissioner Scott Gottlieb, on the illegal sale of these liquids on Thursday. “There are no e-liquid products approved to contain prescription drugs or any other medications that require a doctor’s supervision,” the statement read. “Prescription drugs are carefully evaluated and labeled to reflect the risks of the medications and their potential interactions with other medicines, and vaping active drug ingredients is an ineffective route of delivery and can be dangerous.” Gottlieb considers the e-cigarette usage among teenagers an epidemic, he clarified in a statement last [...]

Charlotte Parker2018-10-15T14:38:04-07:00October, 2018|Oral Cancer News|

FDA Cracks Down on Marijuana Cancer Treatment Claims

Author: Anna Edney; Jennifer Kaplan Source: www.bloomberg.com Date: November 1, 2017 U.S. officials sent a warning to the marijuana industry, alerting online sellers they cannot market their products as a treatment for cancer. The Food and Drug Administration sent letters to four companies on Tuesday, warning them about unsubstantiated claims that their marijuana-derived products can combat tumors and kill cancer cells. The firms sell products including oils and capsules made from cannabidiol, also known as CBD, a component of the marijuana plant that doesn’t cause the mind-altering effects of the other main component, tetrahydrocannabinol, or THC. The agency told the companies they cannot make claims to treat or cure a disease when a product has never been studied as a treatment. Curbing the sale of CBD products with health claims could put a damper on the medical-marijuana market. Producers that are required to nix references to medical ailments may move toward the recreational side of the legal cannabis industry. Eight states and Washington, D.C., have legalized pot for recreational use. Twenty-one additional states have legalized for medical purposes. “We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products,” FDA Commissioner Scott Gottlieb said in a statement. The crackdown could also have a wider impact on the pharmaceutical industry. CBD is being researched in labs as potential treatment for certain diseases. [...]

Charlotte Parker2018-02-06T15:02:17-07:00November, 2017|Oral Cancer News|

FDA Approves First Gene Therapy For Leukemia

Source: npr.org Author: Rob Stein Date: August 30, 2017 The Food and Drug Administration on Wednesday announced what the agency calls a "historic action" — the first approval of a cell-based gene therapy in the United States. The FDA approved Kymriah, which scientists refer to as a "living drug" because it involves using genetically modified immune cells from patients to attack their cancer. The drug was approved to treat children and young adults up to age 25 suffering from a form of acute lymphoblastic leukemia who do not respond to standard treatment or have suffered relapses. The disease is a cancer of blood and bone marrow that is the most common childhood cancer in the United States. About 3,100 patients who are 20 and younger are diagnosed with ALL each year. "We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer," FDA Commissioner Scott Gottlieb said in a written statement. "New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses," Gottlieb said. The treatment involves removing immune system cells known as T cells from each patient and genetically modifying the cells in the laboratory to attack and kill leukemia cells. The genetically modified cells are then infused back into patients. It's also known as CAR-T cell therapy. "Kymriah is a first-of-its-kind treatment approach that fills an important [...]

Charlotte Parker2017-08-31T15:18:44-07:00August, 2017|Oral Cancer News|

FDA Warns Against So-Called “Cancer Cure”

Source: http://www.curetoday.com/articles/fda-warns-against-socalled-cancer-cure Published: 01/13/2017 Author: BRIELLE URCIUOLI The US Food and Drug Administration (FDA) just added another agent, PNC-27, to the growing list of drugs that falsely claim to treat or cure cancer. An FDA lab recently found the bacteria Variovorax paradoxus in PNC-27, a product that is claiming to treat and cure all cancers, claiming to affect lung cancer as affectively as head and neck cancer. Though no illness or serious adverse events were reported to the FDA, contact with contaminated samples can lead to life-threatening infections, especially in vulnerable populations, such as young children, elderly people, pregnant women and people who have weakened immune systems, according to a statement released by the FDA. “In general, consumers should be cautious of products marketed and sold online claiming to treat, cure or prevent any disease. Products claiming to treat, cure or prevent disease, but are not proven safe and effective for those purposes not only defraud consumers of money, they can lead to delays in getting proper diagnosis and treatment of a potentially serious condition,” Kristofer Baumgartner, FDA spokesperson, said in an interview with CURE. PNC-27 is being dosed in multiple ways, such as a nebulized solution, intravenous solution, vaginal suppository or rectal suppository. The FDA is urging people not to purchase or use PNC-27, which is neither FDA evaluated or approved. Patients should consult with their licensed health care providers before deciding on a treatment plan, and if they have already taken PNC-27, they should see their doctor as [...]

Charlotte Parker2017-01-17T10:39:51-07:00January, 2017|Oral Cancer News|

Why the FDA Wants More Control over Some Lab Tests

The FDA finds that many so-called laboratory-derived tests may actually harm patients By Charles Schmidt | Scientific American December 2016 Issue Every year in the U.S., doctor's offices and hospitals order billions of laboratory tests to measure everything from cholesterol levels in the blood to the presence of a gene thought to increase the risk of developing Alzheimer's disease. Physicians and patients typically assume that they can trust the results of these tests. And most of the time they can. But not all lab tests are equally reliable, and faulty ones can have serious consequences. Sometimes they fail to detect life-threatening conditions. Other times they indicate a problem that does not exist, which can lead to unneeded, perhaps even dangerous treatments. Through a quirk of regulatory history, many such tests are not subject to the same medical standards as other tools used to identify risk for disease or to definitively diagnose a condition. These are called lab-developed tests, or LDTs, defined as tests that are manufactured and interpreted by the same individual lab that designed them—in contrast to, say, a quick strep test meant to be used and understood by a wide variety of personnel in doctor's offices everywhere. Most people first encounter an LDT during a checkup when the physician is faced with a diagnostic dilemma that cannot be resolved by widely available blood tests. The trouble is, experts believe many of these tests are not useful, and some may even cause harm by convincing too many people that [...]

Charlotte Parker2016-11-28T10:49:07-07:00November, 2016|Oral Cancer News|

Expert Asserts Pembrolizumab to Play Important Role in Head and Neck Cancer Treatment

Source: www.targetedonc.com Author: Laura Panjwani The FDA approval of pembrolizumab (Keytruda) as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in August 2016 was extremely significant for this patient population, which previously had limited options following progression on a platinum-based chemotherapy. The approval was based on the phase Ib KEYNOTE-012 study, which demonstrated that pembrolizumab had an overall response rate (ORR) of 18% and a stable disease rate of 17% in patients with recurrent/metastatic HNSCC. Several other studies are further evaluating the immunotherapy agent in HNSCC.Preliminary results of the phase II KEYNOTE-055 study—which included 92 evaluable patients who received pembrolizumab after failing platinum and cetuximab therapies—were presented at the 2016 ASCO Annual Meeting. In an interview with Targeted Oncology, lead study author Joshua M. Bauml, MD, an assistant professor of Medicine, Hospital of the University of Pennsylvania and the Veteran's Administration Medical Center, discusses the impact of pembrolizumab’s success in HNSCC, the results of the KEYNOTE-055 study, and what he sees on the horizon for the PD-1 inhibitor in this field. TARGETED ONCOLOGY: What role do you envision pembrolizumab having in this patient population? Baumi: It is going to play a critical role in head and neck cancer. The other agents that are available have limited efficacy, and are associated with significant toxicities. This is a clear improvement for our patient population with limited options. TARGETED ONCOLOGY: What were the key takeaways from KEYNOTE-055? Baumi: Patients with recurrent/metastatic head and neck cancer that [...]

Charlotte Parker2016-09-22T14:29:26-07:00September, 2016|Oral Cancer News|

Expert says Nivolumab Poised to Change Standard of Care in SCCHN

Source: www.onclive.com Author: Laura Panjwani Nivolumab (Opdivo) is a game-changing agent for the treatment of patients with squamous cell carcinoma of the head and neck (SCCHN), according to Robert L. Ferris, MD, PhD. “Recent findings have shown us that this agent is really the new standard-of-care option for all platinum-refractory patients with head and neck cancer,” says Ferris, vice chair for Clinical Operations, associate director for Translational Research, and co-leader of the Cancer Immunology Program at the University of Pittsburgh Cancer Institute. “This is regardless of whether patients are PD-L1–positive or negative or whether they are HPV-positive or negative.” The PD-L1 inhibitor received a priority review designation by the FDA in July 2016 based on the CheckMate-141 study, which demonstrated a median overall survival (OS) with nivolumab of 7.5 months compared with 5.1 months with investigator's choice of therapy (HR, 0.70; 95% CI, 0.51-0.96; P = .0101) in patients with recurrent or metastatic SCCHN. The objective response rate (ORR) was 13.3% with nivolumab and 5.8% for investigator's choice. The FDA is scheduled to make a decision on the application for the PD-1 inhibitor by November 11, 2016, as part of the Prescription Drug User Fee Act. Ferris was the lead author on an analysis that further evaluated preliminary data from CheckMate-141, which was presented at the 2016 ASCO Annual Meeting. In an interview with OncLive, he discusses the findings of this study, potential biomarkers for nivolumab, and questions that remain regarding the use of the immunotherapy in SCCHN. OncLive: What [...]

Charlotte Parker2016-08-24T13:28:58-07:00August, 2016|Oral Cancer News|