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The US Food and Drug Administration approved two cancer treatments, Vitrakvi and Xospata, this week after expedited reviews.Vitrakvi, approved Monday, is "a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker)."The FDA said in a statement that it is the second approved cancer treatment that is based on a tumor biomarker instead of the place in the body where the tumor originated.Vitrakvi will be used for the treatment of solid tumors that have an NTRK (neurotrophic receptor tyrosine kinase) gene fusion that do not have a known resistance mutation, that are not metastatic or where surgical removal is likely to lead to severe morbidity, and that have no alternative treatments or have progressed after treatments.NTRK genes are rare but occur in many types of cancer, the FDA said, such as mammary analogue secretory carcinoma and infantile fibrosarcoma.Xospata tablets, approved Wednesday, are for the "treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation," according to the FDA.Alongside the tablets, the agency also approved a diagnostic to detect the mutation."Approximately 25 to 30 percent of patients with AML have a mutation in the FLT3 gene. These mutations are associated with a particularly aggressive form of the disease and a higher risk of relapse," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence, said in the statement.AML is a rapidly progressing cancer that affects the numbers of normal blood cells and calls for continuous transfusions, the FDA said.Both treatments were granted Priority Review designation.Priority Review, established in 1992, means the FDA aims to review the drug or treatment within six months, opposed to 10 months for a standard review."A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications," the FDA says.Both treatments also received?orphan drug?designation, a status granted to drugs for rare diseases or conditions. 2261

The Trump administration is considering a new travel ban to replace its original executive order, which has had its legality questioned and is up for a Supreme Court hearing next month, White House national security adviser H.R. McMaster said Sunday."Well, this is something that we're looking at, is how to protect the American people better, how to ensure that we know who these people are who are moving," McMaster told George Stephanopoulos on ABC's "This Week."This renewed discussion of the travel ban comes after Friday morning's terrorist attack in London, in which 30 passengers on a London Underground train were injured after a bomb went off.In a tweet Friday in response to the attack, President Donald Trump called for a "larger, tougher and more specific" travel ban and also called for shutting down terrorist group's use of the internet for indoctrination and recruitment.McMaster echoed the point Sunday."Because of the strength of these terrorist organizations -- why this is a greater danger than ever -- is, first of all, their ability to communicate, to connect what would otherwise be disconnected cells in other places in the world," he said. "The second part of this is their ability to travel and to move and to move people and money and weapons, oftentimes drugs and other illicit goods, internationally. So part of the strategy must be to interdict these networks, interdict them from how they use information, and communicate, but how they move physically, as well.The Supreme Court is set to hear?oral arguments in the travel ban case early next month.The President's executive order would suspend travel from six Muslim-majority countries (Iran, Libya, Somalia, Sudan, Syria and Yemen) for 90 days while the secretary of homeland security and others submit a report on the results of a worldwide review to identify what additional information will be needed from each country to make sure an individual seeking entrance is not a public-safety threat.Responding to a lawsuits from states challenging the ban, the Supreme Court let much of the ban take effect in late June, meaning the 90-day clock started and will hit on or around September 24.Administration officials have not divulged the specifics of their future plans.At a recent homeland security conference in Washington DC, acting Customs and Border Protection Deputy Commissioner Ronald Vitiello said, "We are in the process of action planning about each of the opportunities that the US government has to interview and/or vet potential inbound travelers."That could include "looking at things like social media, looking at things like smart phones, those kinds of windows, if you will, into people's backgrounds and their activity," he said.The-CNN-Wire 2771

The White House does not appear to be making any changes to current virus protocol, even after President Donald Trump and the first lady tested positive for COVID-19.A senior White House official said Friday that masks will still not be mandatory at the White House, describing facial coverings as “a personal choice,” despite overwhelming evidence that they help to stop the spread.And the White House is not planning to move to a different, more reliable testing system after the one it uses failed to detect that adviser Hope Hicks had the virus the day she began experiencing symptoms.The president, his White House and his campaign have generally taken a lax approach to the pandemic, continuing to hold large events and failing to abide by social distancing recommendations.The official, who spoke on condition of anonymity to discuss internal White House thinking, defended the current system. 908

The United States is on pace to see its highest number of overdose deaths ever since record keeping began.Between October 2019 and October 2020, 74,000 overdose deaths were reported in the country, up from 68,000 during the same time period the previous year.In local municipalities, the numbers are even more staggering as many cities already surpassed their 2019 numbers through the first nine months of this year, and experts say the pandemic is only fueling the rise.The Associated Press analyzed preliminary overdose statistics in nine states across the country: Colorado, Kentucky, Texas, Connecticut, Massachusetts, Missouri, Rhode Island, New Jersey, and Washington. All of the states showed marked increased in overdose numbers from 2019 to 2020.In Colorado, for example, overdose deaths increased by 28%. In Denver, specifically, that rise was being fueled by the opiate fentanyl, which has been trafficked more across the U.S. Mexico border during the pandemic due to its strength.According Denver’s Medical Examiner’s Office, fentanyl deaths increased tenfold between 2018 and 2020. In 2019, the city reported 56 overdoses from the drug. Through October of this year, that number has skyrocketed to 108.“Drug overdoses are exceeding every metric that we’ve seen for the last decade,” said Dr. Jim Caruso, who is the coroner for the City and County of Denver. “We have had fentanyl related deaths in individuals as young as nine years old. Kids are always tough and they’ve been tough my whole career because you’re looking at the most lost years of productive life.”Dr. Ken Leonard is the Director of the Research Institute on Addictions at the University of Buffalo and says since the start of the pandemic, overdose deaths have only increased at a faster rate, particularly among those with existing drug issues.According to the AP’s analysis, deaths in all nine states peaked in either April or May, just after the tightest stages of quarantine began.Dr. Leonard says the economic consequences of the pandemic forced many drug treatment centers to either furlough or cut employees to save money, affecting accessibility to treatment. He says the isolation from support networks during quarantine may have also played a role in the rise.“The pandemic and the isolation, for a lot of people the unemployment, it all creates a tremendous amount of stress,” said Leonard.Because it takes months to tabulate national overdose death numbers, the true extent of what is happening may not be known until next year, despite early indicators that we are already in the midst of an unprecedented drug epidemic taking place during this pandemic. 2656

The Supreme Court on Tuesday invalidated a provision of federal law that requires the mandatory deportation of immigrants who have been convicted of some crimes, holding that the law is unconstitutionally vague.The case, Sessions v. Dimaya, had been closely watched to see if the justices would reveal how they will consider the Trump administration's overall push to both limit immigration and increase deportations.As expected after the oral argument, Justice Neil Gorsuch joined with the more liberal justices for the first time since joining the court to produce a 5-4 majority invalidating the federal statute. In doing so, Gorsuch was continuing the jurisprudence of Justice Antonin Scalia, who also sided with liberals when it came to the vagueness of statutes used to convict criminal defendants.Only eight justices heard the case last term after Scalia's death, and in late June, the court announced it would re-hear arguments this term, presumably so that Gorsuch could break some kind of a tie.Dimaya, a native of the Philippines, was admitted to the United States in 1992 as a lawful permanent resident. In 2007 and 2009, he pleaded no contest to charges of residential burglary in California and an immigration judge determined that Dimaya was removable from the US because of his two state court convictions.The court held that the convictions qualified for an "aggravated felony" under the Immigration and Nationality Act, which authorizes removal of non-citizens who have been convicted of some violent crimes and defines aggravated felony to include "crimes of violence."Lawyers for Dimaya appealed the removal arguing that it was unconstitutionally vague and that their client never had fair notice that his crimes would result in deportation.They suggested the reasoning of a 2015 Scalia opinion, which struck a provision of the Armed Career Criminal Act as unconstitutionally vague, should extend to their case.  1945