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Merck’s Keytruda wins FDA approval to treat head and neck cancer

Source: Reuters
Date: June 11, 2019
Author: Reporting by Aakash Jagadeesh Babu; Editing by Shailesh Kuber

(Reuters) – Merck & Co Inc said on Tuesday its blockbuster cancer drug Keytruda won approval from the U.S. Food and Drug Administration to treat a type of head and neck cancer.

The drug was approved for use as a monotherapy, as well as in combination with a common chemotherapy regimen, to treat previously untreated patients with head and neck squamous cell carcinoma, Merck said.

The approval is based on results from a late-stage trial, where Keytruda showed a significant improvement in overall survival in cancer patients, Merck said.

Keytruda, a type of immunotherapy called a PD-1 inhibitor, is already an approved treatment for several forms of cancer, including lung and skin cancers.

Head and neck cancer includes tumors in the mouth, tongue, nose, sinuses, throat and lymph nodes in the neck.

Merck estimates that there will be more than 65,000 new cases of head and neck cancer diagnosed in 2019 in the United States.

Keytruda works by increasing the ability of patients’ immune system to help detect and fight tumor cells.

The drug has been amassing approvals as a standalone therapy and in combination with other drugs to treat several forms of cancer. It is the leading immunotherapy for treating lung cancer, ahead of rival drugs from Bristol-Myers Squibb, Roche and AstraZeneca.

Keytruda, first approved for advanced melanoma in 2014, is Merck’s most important growth driver. It has overtaken Bristol’s Opdivo as the industry’s immuno-oncology leader with sales expected to top $10 billion this year and $20 billion in 2024, according to IBES data from Refinitiv.

Keytruda brought in revenue of $7.17 billion for Merck in 2018, while Bristol’s Opdivo earned $6.74 billion.

June, 2019|Oral Cancer News|

The HPV Vaccine Is Already Dramatically Lowering Rates of Cervical Disease

Source: Gizmodo
Date: 04/03/19
Author: Ed Cara

A new study out Wednesday in the BMJ is the latest to showcase even the short-term benefits of the human papillomavirus (HPV) vaccine. It found that the routine vaccination of preteen girls in Scotland, starting in 2008, led to drastically lower rates of cervical disease by the time the girls turned 20. That included conditions known to raise the risk of cervical cancer later on in life.

There are over 100 different types of HPV that regularly infect humans. Most types cause no symptoms at all, while some can cause annoying but harmless warts on our hands, feet, or genitals, depending on where they like to call home. High-risk HPV types, however, linger in the cells that line the surfaces of our body, triggering changes that can eventually turn them cancerous. These HPV types account for nearly all cases of cervical cancer, as well as a substantial proportion of cancers in the mouth, throat, anus, and penis.

We’ve had a vaccine available for two of the most common high-risk types of HPV since 2006, when it was at first recommended only for teen girls. Over the years, the window of opportunity for getting the vaccine has expanded, as has the number of HPV types it protects against. The newest version protects against seven high-risk types that account for 90 percent of cervical cancers (along with two types that cause genital warts). And young boys and men are now also encouraged to get the vaccine, as are women up to age 45.

Despite this increase in recommended age, getting vaccinated while young provides the most benefit, since it’s incredibly easy to contract HPV once a person becomes sexually active. But rates of childhood HPV vaccination in places like the U.S. are still abysmally low. According to one estimate, only 35 percent of children are fully vaccinated by age 15 (the current guidelines call for kids to begin their vaccination from age 11 to 12, with only two shots needed if they get both by age 15; otherwise three shots are required). That low adherence rate not only hampers the protective effects of the vaccine, it also complicates efforts by researchers to study the real-world impact of the vaccine on a population.

In countries like Scotland, though, routine HPV vaccination was quickly adopted and made commonplace, thanks to a nationally funded vaccination program that targeted 12- to 13-year-old girls starting in 2008, along with a later program that targeted older teens. But there are other factors that make Scotland an ideal country to test the value of widespread HPV vaccination, according to lead author Tim Palmer, a pathologist at the University of Edinburgh.

“Up until June 2016, we started [cervical disease] screening at age 20, so we’re one of the first countries to have immunized women attend for screening,” he told Gizmodo via email. “We are also one of the few countries to be able to link directly the fact that an individual had or had not been vaccinated and her screening outcome many years later.”

Palmer and his team looked at the records of more than 130,000 women in Scotland who received one of these cervical screenings at age 20. They compared women vaccinated for HPV as young girls to slightly older women vaccinated during the catch-up program and to unvaccinated women born in 1988.

Compared to these unvaccinated women, they found, the women vaccinated as young girls were far less likely to have any kind of cervical disease, defined as the growth of abnormal cells in the cervix. Most importantly, the rate of growths classified as a cervical intraepithelial neoplasia (CIN) grade 3 also dropped substantially, by nearly 90 percent. That’s crucial because a CIN3 growth puts women at their greatest risk of someday developing cervical cancer. According to Palmer, the 90 percent reduction they found is the largest drop seen with CIN3 in any population where HPV vaccination is available.

“Thus, we are confident that the reduction in CIN3 will lead to a reduction in cancers,” Palmer said.

The high vaccination rate in Scotland also had indirect effects, they found. The rate of cervical disease in the minority of women who were eligible but did not get vaccinated dropped as well, meaning vaccine coverage was high enough to provide some herd immunity (put simply, the more protected a population is from a disease, the less opportunity the disease has to spread to unprotected people). As expected, women who were older when vaccinated still had a lower rate of cervical disease than unvaccinated women, but not to the same degree as those who got the vaccine when young.

All in all, Palmer said, the study shows that Scotland’s HPV program has been an unmitigated success, one that will continue to pay off for decades. And Scotland’s early success story should provide plenty more motivation for other countries to drive up their own local vaccination rates.

That said, it’ll still take some time before we can really be sure that cervical cancer rates will similarly plummet, since many women develop it in their mid 30s and 40s. But Palmer says his team is already at work studying screening data that might show the vaccine’s effectiveness at preventing earlier cases of cancer.

The growing success of the HPV vaccine might eventually lead to changes in how we screen women for cervical cancer, Palmer said, since there’ll be fewer total cases of cancer to catch—a welcome problem, obviously.

“Ultimately, when routinely immunized women form the majority of the women eligible for screening, the need for cervical screening programs should be reviewed; they may no longer be justified,” he said. “However, this point will not be reached in Scotland for at least 25 or 30 years. Before that stage, the frequency and number of screening tests will need to be reviewed; there are suggestions that just two or three tests in a screening ‘lifetime’ will be adequate.”

Currently, in the U.S., it’s estimated there are 12,000 new cases of cervical cancer annually.

April, 2019|Oral Cancer News|

The US surgeon general just issued a rare advisory about e-cigs like the Juul — here’s why vaping is so dangerous

In a rare national advisory, the top US public health official warned Americans of the dangers of e-cigarettes like the Juul, a popular device that lets users inhale nicotine vapor without burning tobacco.

US Surgeon General Jerome Adams said in the advisory on Tuesday that e-cigs like the Juul are a particular danger to kids and teens and called for fresh measures to halt their rising popularity.

“We need to protect our kids from all tobacco products, including all shapes and sizes of e-cigarettes,” Adams said in a statement, adding, “We must take action now to protect the health of our nation’s young people.”

The advisory singles out Juul multiple times, saying the sleek devices are popular among teens because they’re easy to conceal and don’t emit much odor. It tells parents, health professionals, and teachers to be on the lookout for all forms of nicotine-delivery devices, including e-cigs.

Adams’ announcement comes on the heels of warnings from several other federal agencies about a rise in e-cig use, including from the Centers for Disease Control and Prevention and the Food and Drug Administration.

In November, after new CDC data pointed to a 78% increase in e-cig use among high-school students, FDA Commissioner Scott Gottliebannounced moves to further restrict sales of e-cigarettes to prevent them from getting into the hands of young people. That included a crackdown on flavored offerings, which researchers say appeal strongly to young people.

Several days before the FDA’s announcement, Juul Labs, the Silicon Valley startup behind the most popular e-cig in the US, temporarily halted sales of its flavored varieties in stores until they agreed to adopt the company’s new age restrictions and a stronger system for making sure customers are at least 21 years old.

‘E-cigarettes and youth don’t mix’

Though smoking conventional cigarettes is uniquely deadly, and vaping appears to be somewhat healthier (especially for adults looking to switch), public health experts are concerned about how e-cigarettes affect young people.

Because of their runaway popularity, e-cigs could create a new generation of Americans hooked on nicotine, one of the world’s most addictive substances and the key ingredient in e-cigs like the Juul, these experts warn. Their concern comes in part from a host of studies suggesting that teens who vape are significantly more likely to go on to smoke regular cigarettes than teens who never vape.

This finding could be related to the way nicotine affects the developing brains of young people. Though the research on e-cigs is still limited because the devices are so new, researchers have a wealth of data on the negative effects of nicotine on teens who start smoking early.

In brain-imaging studies of adolescents who started smoking in their teens, researchers have found signs of reduced activity in the prefrontal cortex, the part of the brain tied to planning and decision-making. The same teens performed worse on memory and attention tasks than teens who didn’t smoke.

Nicholas Chadi, a clinical pediatrics fellow at Boston Children’s Hospital, spoke about the Juul at the American Society of Addiction Medicine’s annual conference this spring. He described some anecdotal effects of nicotine vaping that he’d seen among teens in and around his hospital.

“After only a few months of using nicotine,” the teens “describe cravings, sometimes intense ones,” Chadi said, adding that “after only a few hundred cigarettes — or whatever the equivalent amount of vaping pods — some start showing irritability or shakiness when they stop.”

Most e-cigs contain toxic metals, and using them may increase the risk of a heart attack

Beyond the effects of e-cigs on the developing brain, a host of health issues related to e-cigs is beginning to emerge.

This spring, scientists looked at the compounds in several popular brands of e-cigs aside from the Juul and found some of the same toxic metals that are in conventional cigarettes, such as lead.

A study published this month found that people who vape tended to have high concentrations of some of these toxic chemicals in their bodies.

In another study published this summer, scientists concluded that there was substantial evidence tying daily e-cig use to an increased risk of a heart attack. And this fall, a small study with rats suggested that vaping could have a negative effect on wound healing that’s similar to the effect of regular cigarettes.

But many teens may not be aware of these health risks. Researchers say that could be because so little research has focused on the Juul, which has captured a nearly 80% market share in the US.

So for a study published in October, researchers from Stanford University’s School of Medicine surveyed young people who vaped and asked them whether they used the Juul or another e-cigarette.

From their sample of 445 high-school students, the researchers observed that teens who used the Juul tended to say they vaped more frequently compared with those who used other devices. Juul users also appeared to be less aware of how addictive the devices could be, compared with teens who used other e-cigs.

“I was surprised and concerned that so many youths were using Juul more frequently than other products,” Bonnie Halpern-Felsher, a professor of pediatrics who was a lead author of the study, said in a statement.

“We need to help them understand the risks of addiction,” she added. “This is not a combustible cigarette, but it still contains an enormous amount of nicotine — at least as much as a pack of cigarettes.”

December, 2018|Oral Cancer News|