Breaking News
April 23, 2018 - Freezing hunger-signaling nerve may help ignite weight loss
April 23, 2018 - Wear exoskeletons with caution for heavy lifting, researchers say
April 23, 2018 - Scientists use CRISPR tool to make multiple edits to DNA samples ‘in vitro’
April 23, 2018 - Knee reconstructions are on the rise among the youth in Australia
April 23, 2018 - Artificial sweeteners linked to obesity warn researchers
April 23, 2018 - CDC seeking $400 million to replace lab for deadliest germs
April 23, 2018 - Sensirion to present single-use liquid flow sensor at COMPAMED 2017
April 23, 2018 - FDA approves contact lenses that shade the sun
April 22, 2018 - Concussion recovery and symptom severity found to vary between men and women
April 22, 2018 - C. Difficile Risk Higher With Stoma Reversal Versus Colectomy
April 22, 2018 - Repeated ranibizumab doesn’t impair macular perfusion
April 22, 2018 - New microscope reveals how cells behave in 3D and real time inside living organisms
April 22, 2018 - Study shows clinical benefit and monetary gains of weight-loss surgery
April 22, 2018 - GNA Biosolutions launches world’s first Laser PCR platform at Medica Trade Fair
April 22, 2018 - Researchers present simulation model to investigate hospital responsiveness to mass casualty incidents
April 22, 2018 - Does Pot Really Dull a Teen’s Brain?
April 22, 2018 - Controversial pregnancy test drug shows deformities in zebrafish embryos within hours of exposure
April 22, 2018 - New research partnership makes childbirth safer in Mozambique
April 22, 2018 - Brief bedside visual art intervention reduces pain, anxiety in cancer patients
April 22, 2018 - The memory part of the brain may also hold clues for anxiety and depression
April 22, 2018 - AYOXXA to develop multiplex immunoassay to support treatment of sepsis patients
April 22, 2018 - New Drug Combo Ups Survival in HER2/neu Uterine Serous Cancer
April 22, 2018 - Researchers chart a new way to look at concussion
April 22, 2018 - Every parent needs to know fundamental red flags for autism
April 22, 2018 - Anatotemp expands anatomic dental implant healing abutments with 4Side anti-rotational connection
April 22, 2018 - Gene Twist Can Make Your Blood Pressure Spike From Salt
April 22, 2018 - Study suggests failed osteoarthritis drug could help treat opioid addiction
April 22, 2018 - More Americans aware of growing problem of opioid addiction
April 22, 2018 - KHN’s ‘What the Health?’ Nothing in health care ever goes away
April 22, 2018 - BGS to promote high-quality sterilization services at Health GB in Manchester
April 22, 2018 - New integrated POC tool detects biomarkers of heart failure rapidly and precisely
April 22, 2018 - Direct electrical current can be delivered to nerves for blocking pain signals
April 22, 2018 - Newly Published Phase 2 Study Found Esketamine Demonstrated Significantly Rapid Improvements in Depressive Symptoms and Suicidality
April 22, 2018 - Healthy red blood cells owe their shape to muscle-like structures
April 22, 2018 - Researchers present case study of management of rheumatic mitral regurgitation in woman contemplating pregnancy
April 22, 2018 - New black Porvair Krystal UV Quartz microplates for Circular Dichroism measurements
April 22, 2018 - Advanced flow chemistry modules enhance control of nanoprecipitation
April 22, 2018 - Look! Down in the petri dish! It’s a superplatelet!
April 22, 2018 - Research reveals why people with tetraplegia more likely to suffer from sleep apnea
April 21, 2018 - New non-invasive nerve stimulation may offer relief for people with hand tremor
April 21, 2018 - Smartphone App May Up Medication Adherence in HTN
April 21, 2018 - Western diet depletes artery-protecting immune cells
April 21, 2018 - Excelitas Technologies launches new powerful LED light source for fluorescence microscopy
April 21, 2018 - Academia and high tech companies join forces to increase production capacity for microfluidic systems
April 21, 2018 - Developing cooking skills as young adult may have long-term health benefits
April 21, 2018 - Study compares survival outcomes of different drugs for type 2 diabetes
April 21, 2018 - More Than 40 Percent of Americans Breathe Dirty Air: Report
April 21, 2018 - Obstructive sleep apnea – Genetics Home Reference
April 21, 2018 - More evidence shows exposure to traffic and outdoor air pollution increases risk of asthma
April 21, 2018 - Novel gold nanoparticle technology could guide cancer treatment in real-time
April 21, 2018 - News coverage of Ebola impacted public’s perception on disease and survivors
April 21, 2018 - S.Africa’s DIY battle against HIV
April 21, 2018 - Children with autism have gastrointestinal and immune system deregulation, research finds
April 21, 2018 - Human brain processes sight and sound in the same way, shows study
April 21, 2018 - Evolutionary history of tumor helps predict severity of prostate cancer
April 21, 2018 - Pepper plant metabolizes antibiotic in personal care products
April 21, 2018 - Tradeshow Talks with Integra
April 21, 2018 - EPFL becomes part of Chan Zuckerberg’s project to develop Human Cell Atlas
April 21, 2018 - Pfizer Announces Positive Topline Results From Phase 3 ATTR-ACT Study Of Tafamidis In Patients With Transthyretin Cardiomyopathy
April 21, 2018 - Breaking through the HIV vaccine ‘logjam’
April 21, 2018 - IntelliCyt introduces new QSol buffer to enable robust, consistent sampling
April 21, 2018 - Scientists publish comprehensive lineage tree of whole adult animal in Science journal
April 21, 2018 - Innovative method based on FluidFM technology could revolutionize biological research
April 21, 2018 - Americans world’s biggest TV addicts, watching four hours a day
April 21, 2018 - Investigational drug may help increase protein levels in babies with spinal muscular atrophy
April 21, 2018 - Study shows distinctions between age groups in predicting and responding to stress at home
April 21, 2018 - Aziyo Biologics, BIOTRONIK enter into US co-distribution agreement
April 21, 2018 - Opiate Use Linked to Early Mortality in IBD Patients
April 21, 2018 - Online ads help pregnant smokers quit
April 21, 2018 - Opioid pain medications may not be safe for hemodialysis patients
April 21, 2018 - Rare variants in non-coding DNA inherited from parents heighten autism risk
April 21, 2018 - A needleless glucose monitor for diabetes patients
April 21, 2018 - BD introduces new informatics and automation solutions for clinical laboratories
April 21, 2018 - Turn Chores Into a Fitness Routine
April 21, 2018 - DNA methylation plays key role in stem cell differentiation
April 21, 2018 - Scientists find link between soil metals and cancer mortality
April 21, 2018 - Experts discuss implications of low calcium intake in global population
April 21, 2018 - GNA Biosolutions to display Pharos V8 Laser PCR instrument at Analytica trade fair
April 21, 2018 - People with vitamin D deficiency may be at greater risk of diabetes
April 21, 2018 - Study findings could open new possibilities for treating cancer with adenovirus
FDA Approves ALK-Centered Drug for NSCLC

FDA Approves ALK-Centered Drug for NSCLC

image_pdfDownload PDFimage_print

WASHINGTON — The FDA as of late granted sped up approval to brigatinib for remedy of metastatic ALK-positive non-small mobile lung most cancers (NSCLC) that has improved throughout or after remedy with crizotinib (Xalkori).

The company accepted the drug at the foundation of effects from a segment II, noncomparative trial comparing two doses of brigatinib (90 and 180 mg). The learn about concerned 222 sufferers with metastatic NSCLC up to now handled with crizotinib. All sufferers had tumors with ALK rearrangement documented through an FDA-approved check or ok tissue to verify ALK rearrangement by way of a fluorescence in-situ hybridization assay.

Knowledge confirmed an function reaction fee of 48% with the decrease dose of brigatinib and 53% with the upper dose. After an Eight-month median period of follow-up, sufferers in each remedy fingers had a mean period of reaction of 13.Eight months. The subgroup of sufferers with mind metastases had an intracranial function reaction fee of 42% with 90 mg (n=26) and 67% with 180 mg (n=18).

A security research that incorporated 219 sufferers who gained a minimum of one dose of brigatinib confirmed that the most typical hostile occasions (≥25% of sufferers) have been nausea, diarrhea, fatigue, cough, and headache. The most typical severe hostile occasions have been pneumonia and interstitial lung illness/pneumonitis. The occurrence of deadly hostile occasions used to be three.7%, consisting of 2 deaths due to pneumonia and one each and every to surprising dying, dyspnea, respiration failure, pulmonary embolism, bacterial meningitis, and urosepsis. Opposed occasions resulted in discontinuation of two.Eight% and eight.2% of sufferers within the 90- and 180-mg teams.

Brigatinib is being advanced through ARIAD Prescribed drugs, a subsidiary of Takeda. As a situation of sped up approval, the corporate should habits any other medical trial to verify the result of the segment II learn about.

2017-04-28T18:28:44-0400

Tagged with:

About author

Related Articles