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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 White House physician assigned to Vice President Mike Pence, Jennifer Pena, has resigned, his office told CNN in a statement Friday. Pena worked in the White House medical unit."The vice president's office was informed today by the White House Medical Unit of the resignation. Physicians assigned to the vice president report to the White House Medical Unit and thus any resignation would go entirely through the Medical Unit, not the vice president's office," Alyssa Farah, Pence's press secretary, said in a statement to CNN.This comes after CNN reported Tuesday that a Pence doctor privately raised alarms within the White House last fall that President Donald Trump's doctor Ronny Jackson may have violated federal privacy protections for a key patient -- Pence's wife, Karen -- and intimidated the vice president's doctor during angry confrontations over the episode.  890

The Transportation Security Administration says they found three times the rate of loaded guns at checkpoints in July than they did at the exact time last year, despite fewer passengers traveling due to the coronavirus pandemic.In a press release, the agency said that 80% of the firearms that come through a checkpoint are loaded. "It’s just an accident waiting to happen," TSA Administrator David Pekoske said in the release.TSA said they found 15.3 guns per million people screened last month, which is up from the rate of 5.1 guns per million people in July 2019.The agency says that's alarming because they screened 75% fewer travelers last month.“TSA is diligently working to ensure our employees and passengers are safe and secure while traveling during a pandemic, and yet we are noticing a significant increase in loaded firearms coming into checkpoints,” said Pekoske in the press release. “Travelers must understand that firearms are prohibited items at airports and in the passenger cabins of aircraft. As hard as we are working to mitigate other risks at this time, no one should be introducing new ones.”Guns are permitted in checked bags, but they must be unloaded, and in a locked case, TSA said.Last year, 4,432 guns were found in carry-on bags at checkpoints nationwide, which is about 12.1 firearms per day, and 87% of them were loaded, the agency said. 1380

The US surgeon general issued an advisory Thursday recommending that more Americans carry the opioid overdose-reversing drug, naloxone.The drug, commonly known as Narcan, can very quickly restore normal breathing in someone suspected of overdosing on opioids, including heroin and prescription pain medications.Dr. Jerome Adams emphasized that "knowing how to use naloxone and keeping it within reach can save a life." To make his point, Adams relied on a rarely used tool: the surgeon general's advisory. The last such advisory was issued more than a decade ago and focused on drinking during pregnancy.Adams noted that the number of overdose deaths from prescription and illicit opioids doubled in recent years: from 21,089 deaths across the nation in 2010 to 42,249 in 2016.America's top doctor attributed this "steep increase" to several contributing factors, including "the rapid proliferation of illicitly made fentanyl and other highly potent synthetic opioids" and "an increasing number of individuals receiving higher doses of prescription opioids for long-term management of chronic pain.""Research shows that when naloxone and overdose education are available to community members, overdose deaths decrease in those communities," Adams said. Naloxone is used by police officers, first responders and emergency medical techs to reverse opioid overdoses. Adams added that increasing both the availability of naloxone and effective treatment is critical to ending the opioid epidemic.Speaking at the National Prescription Drug Abuse & Heroin Summit in Atlanta on Thursday morning, Adams addressed the potential "moral conflict" felt by some people who believe that providing naloxone "doesn't make a difference," since many people with drug addictions will just "go on and misuse substances again.""Well, that would be like me saying 'I'm not gonna go do surgery on this trauma patient because they're just gonna go out and speed again,' " he said.Adams noted that in most states, people who are or who know someone at risk for opioid overdose can get trained to use naloxone properly and also may receive naloxone by "standing order" -- without a prescription -- from pharmacies or some community-based programs."No mother should have to bury their child ,and especially not when there's a life-saving medication that virtually anyone can access," Adams said. "It is for this reason that I am issuing the first Surgeon General's Advisory in 13 years."The-CNN-Wire 2484

The Senate Intelligence Committee's leaders said Wednesday they believed that the intelligence community's 2017 assessment of election meddling was correct, breaking with Republicans on the House Intelligence Committee who questioned the conclusion that the Russians were trying to help President Donald Trump get elected."There is no doubt that Russia undertook an unprecedented effort to interfere with our 2016 election," Senate Intelligence Chairman Richard Burr, a North Carolina Republican, said in a statement. "Committee staff have spent 14 months reviewing the sources, tradecraft, and analytic work, and we see no reason to dispute the conclusions."The top Democrat on the committee, Sen. Mark Warner of Virginia, said that "after a thorough review, our staff concluded that the ICA conclusions were accurate and on point. The Russian effort was extensive, sophisticated and ordered by President Putin himself for the purpose of helping Donald Trump and hurting Hilary Clinton." 996