Breaking News
March 27, 2019 - Managing MS
March 27, 2019 - Researchers reveal how receptor TLR-9 protects against lupus
March 27, 2019 - Doctors share story of daughter’s treatment for leukemia
March 27, 2019 - Medical Center Hosts Networking Session for Women’s History Month
March 27, 2019 - Positive link found between anxiety during childhood, adolescence with later alcohol use disorders
March 27, 2019 - Coronary artery calcium indicates patients’ imminent risk of a heart attack
March 27, 2019 - Luxia Scientific partners with Life Genomics to commercialize microbiome-based tests in the Nordic countries
March 26, 2019 - New mathematical algorithm objectively classifies shapes of neurons in the brain
March 26, 2019 - Research suggests oxytocin as potential new obesity treatment
March 26, 2019 - Education may not protect against dementia as previously thought
March 26, 2019 - Stanford acquires archive of palliative care pioneer Elisabeth Kübler-Ross | News Center
March 26, 2019 - New research aims to turn worms against parasite-associated cancer
March 26, 2019 - Psychological evolution may help explain differences between male and female serial killers
March 26, 2019 - New molecular mechanism involved in pancreas repair identified
March 26, 2019 - Obesity linked to reproductive problems in women with type 1 diabetes
March 26, 2019 - New short-pulse ultrasound technique enhances drug delivery to brains of mice
March 26, 2019 - Researchers uncover mechanism that initiates sexual organs maturation
March 26, 2019 - DermBiont Begins Phase 2 Clinical Trial for Athlete’s Foot with a Live Bacterial Topical Probiotic
March 26, 2019 - Persons with Alzheimer’s disease have a higher risk of head injuries
March 26, 2019 - Mental health issues associated with income inequalities in Indigenous people
March 26, 2019 - Participation in sports linked with fewer depressive symptoms in children
March 26, 2019 - Brain process common to sleep and aging discovered
March 26, 2019 - People under age 50 with hearing loss more likely to misuse alcohol and drugs
March 26, 2019 - People with and without cancer use different dosages of cannabis formulations, study shows
March 26, 2019 - Young people at risk of addiction show differences in key brain region
March 26, 2019 - In virtual exchange, students in California and Lebanon unite to improve refugee health
March 26, 2019 - Trump Administration Changes Course, Asks Court To Strike Down ACA
March 26, 2019 - People with untreated diabetes develop signs of Alzheimer’s disease at a faster rate
March 26, 2019 - Study explains how bright colors evolved and diversified in male guppies
March 26, 2019 - Savings from lower insurance costs of growth hormone drugs not passed on to patients
March 26, 2019 - Study highlights the need to pay more attention on specific nutritional needs of female athletes
March 26, 2019 - Sleep quality varies throughout menstrual cycle in young women
March 26, 2019 - A1c diabetes blood test found to be unreliable
March 26, 2019 - Younger Female Blood Donors Vulnerable to Iron Deficiency
March 26, 2019 - Prostate cancer cells ‘spit out’ a protein that promotes tumor growth
March 26, 2019 - Finding the elusive drinking ‘brake’
March 26, 2019 - Using the Mastermind strategy in brain research
March 26, 2019 - Symptomatic pharmacotherapy of elderly people should be regularly monitored
March 26, 2019 - Synthetic biological logic gate could one day be used to modify cellular function
March 26, 2019 - Damage to anxiety-associated brain region heightens monkeys’ defensive response
March 26, 2019 - Researchers uncover large-scale brain patterns and networks which control sleep
March 26, 2019 - Scientific Symposium at LABVOLUTION focuses on key issues in life sciences
March 26, 2019 - Screen time plus snacking could increase risk for metabolic syndrome in teens
March 26, 2019 - Attention, Seniors: Drink More Water and Head Off Disease
March 26, 2019 - Peptide shows promise for protecting kidneys from nephritis
March 26, 2019 - Causes of diabetes decline or disappear when ‘zombie cells’ are removed, shows study
March 26, 2019 - Scientists identify common genetic variants associated with post-stroke recovery
March 26, 2019 - Study finds link between menopause and changes in body composition
March 26, 2019 - Higher levels of sex hormones in older men related to lower biological age
March 26, 2019 - Research links participation in team sports to larger hippocampal volumes in children
March 26, 2019 - Cerveau announces research collaboration agreement with Eisai for novel tau imaging agent
March 26, 2019 - New technique measures frequency of sounds emitted from biological structures
March 26, 2019 - Removal of ‘zombie cells’ alleviates causes of diabetes in obese mice
March 26, 2019 - Women exposed to deepwater horizon oil spill continue to experience PTSD symptoms
March 26, 2019 - Shaping new treatments for tuberculosis
March 26, 2019 - Understanding genetic interactions holds key to new personalized therapies
March 26, 2019 - Nervous system relies on guidance cues for neuronal axons to reach destinations
March 26, 2019 - Altering gut microbiome may be potential treatment option for PCOS
March 26, 2019 - Moleculin Files with FDA for Expedited Approval Pathway for Annamycin
March 26, 2019 - GPs play pivotal role in ensuring success of new Faster Diagnosis Standard for Cancer
March 26, 2019 - New clues discovered to lung transplant rejection
March 26, 2019 - New study offers insight into development of delusions
March 26, 2019 - Children’s ball pits full of pathogenic microbes
March 26, 2019 - Exploring pathophysiological factors that link sleep problems and Alzheimer’s disease
March 26, 2019 - Walking downhill after meals can reduce bone resorption in postmenopausal women with diabetes
March 26, 2019 - USA LESS Issues Voluntary Nationwide Recall of LEOPARD Miracle Honey Due to Presence of Undeclared Sildenafil
March 26, 2019 - CT scan prior to spine fusion finds almost half of patients had undiagnosed osteoporosis
March 26, 2019 - After 2 Apparent Student Suicides, Parkland Grieves Again
March 25, 2019 - Inherited form of rickets improves more with new injectable medicine than conventional therapy
March 25, 2019 - Trastuzumab Tied to Higher Long-Term Risk for Heart Failure
March 25, 2019 - Personal context directly affects CPAP use
March 25, 2019 - Mosquito tracking key to preventing disease outbreaks
March 25, 2019 - Scientists Detect Hidden Signals from Beneficial Bacteria
March 25, 2019 - Treating women with thyroid antibodies with Levothyroxine do not increase live birth rate
March 25, 2019 - Brain area that only processes spoken, not written words identified
March 25, 2019 - Race and ethnicity influence fracture risk in diabetic patients
March 25, 2019 - Researchers report new regenerative medicine approach for treating osteoarthritis of the knee
March 25, 2019 - Exposure to dim light at night may contribute to spread of breast cancer to bones
March 25, 2019 - Benefits of osteoporosis treatment in postmenopausal women outweigh the perceived risks
March 25, 2019 - Researchers find evidence of Cryptosporidium parasite in Minnesota’s public water systems
Novartis announces FDA approval of its first and only CML therapy with TFR data in product label

Novartis announces FDA approval of its first and only CML therapy with TFR data in product label

image_pdfDownload PDFimage_print

Novartis announced today that the US Food and Drug Administration (FDA) approved the inclusion of Treatment-free Remission (TFR) data in the Tasigna® (nilotinib) US product label. Tasigna is now the first and only BCR-ABL tyrosine kinase inhibitor (TKI) to include data about attempting treatment discontinuation in eligible adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) after achieving sustained deep molecular response of MR4.5 (BCR-ABL1 International Scale [IS] <= 0.0032%) in its FDA-approved prescribing information. TFR is the ability to maintain a sustained molecular response* after stopping TKI therapy in patients with Ph+ CML-CP. TFR requires scheduled monitoring of BCR-ABL1 levels to identify possible loss of molecular response.

“It has long been our ambition at Novartis to make it possible for some people with CML to discontinue therapy,” said Bruno Strigini, CEO, Novartis Oncology. “We are proud that Tasigna is now the first and only TKI with TFR data in its labeling in the US and several countries around the globe. This achievement would not have been possible without the partnership of patients around the world who participated in our groundbreaking TFR trials, helping Novartis to once again reimagine what is possible for people living with CML.”

With this label update, Tasigna is the only TKI that provides defined, approved criteria to attempt and monitor TFR. This approval follows a priority review for a supplemental New Drug Application (sNDA) for Tasigna seeking the addition of TFR information and is based on safety and efficacy results from the 96-week analyses of two open label trials, ENESTfreedom and ENESTop. These trials evaluated the potential to maintain MMR (BCR-ABL1 <= 0.1%) after stopping Tasigna therapy among eligible adult patients with Ph+ CML-CP. Patients in the trials had achieved a sustained MR4.5 with Tasigna in both the first-line setting or after switching from Glivec® (imatinib). The trials demonstrated that almost half of the Ph+ CML-CP patients who discontinued Tasigna remained in TFR approximately two years after stopping treatment[1]. Among patients who did lose molecular response during the TFR phase of the trials, nearly all regained MMR when Tasigna therapy was promptly reinitiated[1]. The safety data are consistent with previously published studies and the known safety profile of Tasigna.

The TFR data in the Tasigna label approved by the FDA included the use of the MolecularMD MRDxTM BCR-ABL test, a FDA-authorized companion diagnostic validated to measure BCR-ABL transcript levels down to MR4.5. Discontinuation of Tasigna should only be attempted under the close supervision of a physician. Frequently scheduled patient monitoring after Tasigna discontinuation is required so that possible loss of MMR and MR4.0 (BCR-ABL1 IS <= 0.01%) is quickly identified and treatment re-initiation is started promptly.

Source:

https://www.novartis.com/news/media-releases/novartis-drug-tasignar-approved-fda-first-and-only-cml-therapy-treatment-free-remission-data-its-label

d4e171b4-0bed-4e0a-820f-66a29986664a|0|.0

Posted in: Medical Condition News | Pharmaceutical News

Tags: Alopecia, Anemia, Arthralgia, Ascites, Blood, Bone, Cancer, Chromosome, Chronic Myelogenous Leukemia, Chronic Myeloid Leukemia, Clinical Trial, Constipation, Diarrhea, Drugs, Edema, EU, Eye, Fatigue, Gastrectomy, Headache, Health Care, Healthcare, Heart, Heart Disease, Hepatitis B, Ischemic Heart Disease, Kinase, Kinase Inhibitor, Leukemia, Lipase, Liver, Malignant, Musculoskeletal, Mutation, Myeloid Leukemia, Nausea, Neutropenia, New Drug Application, Oncology, Pain, Pancreatitis, Potassium, Pregnancy, Protein, Pruritus, Pulmonary Edema, Tasigna, Thrombocytopenia, Tumor, Tyrosine, Virus

Tagged with:

About author

Related Articles