Latest news with #BacilleCalmette-Guérin
Yahoo
6 days ago
- Business
- Yahoo
FDA grants expanded access to ImmunityBio's Anktiva for lymphopenia
The US Food and Drug Administration (FDA) has granted expanded access authorisation for ImmunityBio's Cancer BioShield platform, anchored by Anktiva (nogapendekin alfa inbakicept-pmln), to treat lymphopenia in adults with refractory or relapsed solid tumours. The approval applies regardless of tumour type and is intended for those who have progressed after first-line standard-of-care treatments, including radiation, chemotherapy or immunotherapy. Lymphopenia refers to the depletion of critical lymphocytes that are responsible for immunogenic cell death. Treatment-induced lymphopenia can be a consequence of radiation therapy, chemotherapy and certain immunotherapies, as well as steroids. Anktiva is designed specifically to address Bacille Calmette-Guérin (BCG)-unresponsive bladder cancer through its mechanism as an interleukin-15 (IL-15) superagonist that proliferates key lymphocytes. As an IL-15 agonist, Anktiva becomes the first approved therapy with a defined mechanism aimed at restoring levels of the vital immune cells without inducing regulatory T cells, thus providing a solution to reverse this critical immune deficit among cancer patients. Recent results have indicated that reversing lymphopenia using both Anktiva and chimeric antigen receptor-natural killer therapy prolongs median overall survival rates among patients with third to sixth-line metastatic pancreatic cancer. Enhanced benefits were observed when treatment commenced at lower tumour burdens indicated by CA19-9 levels. ImmunityBio founder, executive chairman and global chief scientific and medical officer Dr Patrick Soon-Shiong stated: 'Lymphopenia has long been recognised as a major driver and predictor of early mortality in cancer — yet until now, it has remained unaddressed. 'This FDA authorisation allows all patients with solid tumours suffering from immune collapse following first-line therapy of chemo, radiation or immunotherapy to access Anktiva.' In February 2025, ImmunityBio announced the receipt of regenerative medicine advanced therapy designation from the FDA concerning both Anktiva and CAR-NK. "FDA grants expanded access to ImmunityBio's Anktiva for lymphopenia" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
6 days ago
- Business
- Yahoo
FDA grants expanded access to ImmunityBio's Anktiva for lymphopenia
The US Food and Drug Administration (FDA) has granted expanded access authorisation for ImmunityBio's Cancer BioShield platform, anchored by Anktiva (nogapendekin alfa inbakicept-pmln), to treat lymphopenia in adults with refractory or relapsed solid tumours. The approval applies regardless of tumour type and is intended for those who have progressed after first-line standard-of-care treatments, including radiation, chemotherapy or immunotherapy. Lymphopenia refers to the depletion of critical lymphocytes that are responsible for immunogenic cell death. Treatment-induced lymphopenia can be a consequence of radiation therapy, chemotherapy and certain immunotherapies, as well as steroids. Anktiva is designed specifically to address Bacille Calmette-Guérin (BCG)-unresponsive bladder cancer through its mechanism as an interleukin-15 (IL-15) superagonist that proliferates key lymphocytes. As an IL-15 agonist, Anktiva becomes the first approved therapy with a defined mechanism aimed at restoring levels of the vital immune cells without inducing regulatory T cells, thus providing a solution to reverse this critical immune deficit among cancer patients. Recent results have indicated that reversing lymphopenia using both Anktiva and chimeric antigen receptor-natural killer therapy prolongs median overall survival rates among patients with third to sixth-line metastatic pancreatic cancer. Enhanced benefits were observed when treatment commenced at lower tumour burdens indicated by CA19-9 levels. ImmunityBio founder, executive chairman and global chief scientific and medical officer Dr Patrick Soon-Shiong stated: 'Lymphopenia has long been recognised as a major driver and predictor of early mortality in cancer — yet until now, it has remained unaddressed. 'This FDA authorisation allows all patients with solid tumours suffering from immune collapse following first-line therapy of chemo, radiation or immunotherapy to access Anktiva.' In February 2025, ImmunityBio announced the receipt of regenerative medicine advanced therapy designation from the FDA concerning both Anktiva and CAR-NK. "FDA grants expanded access to ImmunityBio's Anktiva for lymphopenia" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Daily Mail
30-04-2025
- Health
- Daily Mail
Panic as world's deadliest infection is detected at Florida high school
A case of the world's deadliest infectious disease has been confirmed in a school in Florida. State officials confirmed a person infected with active tuberculosis was recently present at Dillard High School in Fort Lauderdale. Officials are yet to specify whether the person was a student, staff or faculty and when exactly they were present on the premises. John Sullivan, chief of communications Broward County Public Schools confirmed in a statement that the officials will soon be on campus to provide testing to staff and students with parental consent. School Principal Alfred Broomfield assured parents no action is needed by the community unless they are contacted. Tuberculosis, also called TB, is a potentially fatal illness caused by the Mycobacterium tuberculosis bacteria. It mainly affects the lungs and can also cause damage to the brain, spinal cord and lymph nodes. It most commonly spreads through the air when infected people cough or speak. Once known as consumption, TB is one of the deadliest diseases in the world and according to WHO, over 10 million people across the globe were diagnosed with the illness out of which nearly two million died. In the US, over 10,000 Americans were diagnosed with the infection and 565 died in 2024, according to the CDC. MR Broomfield said in a letter addressed to school parents: 'DOH-Broward and BCPS [Broward County Public Schools] have identified and notified those individuals who have been determined to be a close contact, at this time. No further action is needed unless you are contacted directly.' Earlier, this year an 'unprecedented' tuberculosis outbreak occurred in Kansas - which left 147 people infected. Out of this 67 people became actively ill and 80 contracted the illness but showed no symptoms. Two patients have died, as of now. In 2024, Florida reported 681 tuberculosis (TB) cases - a nine percent increase from 2023. As of 2025, TB cases are increasing both globally and in the United States due to higher international travel and migration, increased reporting, reactivation of latent TB infections and the lingering effects of the COVID-19 pandemic. Children, older people and those with weak immune systems are most at risk of contracting TB - leading to permanent lung damage, even after successful treatment. TB is mostly spread through an exchange of germs containing the bacteria through the atmosphere. Symptoms of active TB in the lungs usually begin gradually and worsen over a few weeks and signs can include coughing up blood or mucus, chest pains, pain with breathing or coughing, fever, chills and night sweats. People can protect themselves against TB by getting the Bacille Calmette-Guérin (BCG) vaccine, but it is not generally not on the vaccination schedule in the US due to the low risk of infection. If infected, patients are asked to remain isolated and must take antibiotics for six months to treat TB. If left untreated, the bacterial infection can damage the lungs and spread to other parts of their body such as the brain, kidneys and spine. Some people become infected with TB germs that live in the body for years without causing illness. This is known as inactive TB or latent TB. However without treatment, one in 10 people with inactive TB will get sick with active TB disease, according to the CDC.
Yahoo
10-02-2025
- Health
- Yahoo
Tuberculosis Is on the Rise—Should You Get the Vaccine?
Tuberculosis is making headlines as the contagious respiratory disease spreads in the Midwest. Kansas is currently facing one of the largest recorded outbreaks in United States history, according to local health officials and the Centers for Disease Control and Prevention (CDC). The good news: tuberculosis is both preventable and treatable. Here, doctors share everything to know about who should get the vaccine for tuberculosis (TB) and how it can protect your health, plus what symptoms look like. Tuberculosis is an infectious respiratory disease caused by bacteria that typically affects the lungs, but can also impact other organs. It's transmitted through the air when people with TB cough, sneeze or sing—though not from sharing food, shaking hands or kissing, the CDC reports. Also, babies and children are at a higher risk of developing TB. In some cases, tuberculosis germs can live in the body for years without ever making someone sick or being contagious. This is called a latent or dormant TB infection. Without treatment, a latent TB infection can develop into an active TB infection that is contagious, causes symptoms and requires medical treatment. Someone with an active TB infection who is contagious may display symptoms such as: Prolonged cough (sometimes with blood—often the telltale sign) Chest pain Weakness Fatigue Weight loss Fever Night sweats With cases of TB on the rise, you're likely wondering how to protect yourself. The problem? The Bacille Calmette-Guérin (BCG) vaccine for tuberculosis is usually not recommended in the U.S. for adults. 'The TB vaccine is mainly given to babies and small children in countries where TB is common,' says Tess Karre, MD, FCAP, a member of the College of American Pathologists' Microbiology Committee. 'It helps protect against severe forms of the disease such as when it involves the brain or spreads throughout the entire body.' In the U.S., the vaccine isn't used often because TB is rare, and other methods, like testing and antibiotics, are used to control it, Dr. Karre explains. However, some people might still benefit from getting the tuberculosis vaccine, such as: Children who are continually exposed through a family or household member with active TB and who cannot receive preventive treatment for TB infection. Healthcare workers who work in settings with a high risk of exposure to bacteria strains that are resistant to TB antibiotics. Dr. Karre believes it is unlikely that the U.S. will adjust its BCG vaccination guidelines in the near future. Despite the current tuberculosis outbreak, the disease has not reached the level of endemicity in this country necessary to make the benefits of the vaccine outweigh the costs and risks, she explains. As Dr. Karre stated, the best way to manage TB and prevent a latent infection from developing into an active infection is through early diagnosis and treatment. You should seek medical care if you have any of the symptoms listed above—specifically night sweats or coughing up blood, says Lily Grobman, PA, a MinuteMed Contributor. Screening for tuberculosis annually is very important for people who work in high-risk populations, she adds. 'Currently, due to the outbreak of tuberculosis in Kansas, we strongly recommend anyone living there who is at high risk or experiencing symptoms be tested,' Grobman says. 'Consider online services such as for searching for various test sites. Early intervention is key in preventing further spreading of the highly contagious bacteria.' There are two common TB tests to help diagnose the condition:During a tuberculin skin test (TST), a small amount of the TB protein is injected under the skin and evaluated 48 hours later to see if the area becomes raised. A QuantiFERON-TB Gold Test (QFT), or IGRA test, is a blood test that examines how your immune system reacts when a sample of your blood is mixed with TB proteins. 'Once there is a positive TB result, a chest x-ray will be done to detect any active disease,'Grobman says. 'Both active and latent tuberculosis will need to be treated, but with different medication regimens.' Your doctor will prescribe one or more medications to treat a tuberculosis infection. Active infections are typically treated for four, six or nine months, while latent infections may be treated for three to four months, the Mayo Clinic reports. More info on respiratory illnesses: How to Test Yourself for COPD at Home, Plus Early Warning Signs It's Time to See a Doctor What Is White Lung Pneumonia, and Should You Be Worried This Sick Season? A Lung Doctor Weighs In RSV Symptoms in Adults: How To Tell if Your Cough Is More Than Just a Cold This content is not a substitute for professional medical advice or diagnosis. Always consult your physician before pursuing any treatment plan.
