Breaking News
August 18, 2018 - Researchers win multi-million Euro award to conduct research into liver disease
August 18, 2018 - Survey highlights variations in practice of airway management in pediatric intensive care units
August 18, 2018 - UK students win sponsorship from Promega Corporation
August 18, 2018 - Janssen Reports Positive Topline Results for ATLAS Phase III Study of a Novel, Long Acting Injectable Two-Drug Regimen for the treatment of HIV-1
August 18, 2018 - PSD as a molecular platform for understanding synapse formation and plasticity
August 18, 2018 - Improved visual communication could help patients to make informed health-care decisions
August 18, 2018 - New algorithm helps identify and manage diabetic patients at increased fracture risk
August 18, 2018 - Microscopic insect odour detecting mechanisms discovered
August 18, 2018 - Researchers develop new approach to study how tuberculosis infects people
August 18, 2018 - FDA Approves Kalydeco (ivacaftor) for Cystic Fibrosis in Children Ages 12 to
August 18, 2018 - An ion channel differentiates newborn and mature neurons in the adult brain
August 18, 2018 - Socio-economic position associated with pregnant women’s exposure to environmental hazards
August 18, 2018 - Voters to settle dispute over ambulance employee break times
August 18, 2018 - AGA urges policymakers and stakeholders to improve affordability of drugs
August 18, 2018 - Increasing dietary protein may lower risk of diabetes in people with NAFLD
August 18, 2018 - New HIV therapy suppresses viral replication and increases immune cells in drug-resistant patients
August 18, 2018 - Broad Genetic Testing for NSCLC May Not Improve Survival
August 18, 2018 - Discovery opens door for synthetic opioids with less addictive qualities
August 18, 2018 - Transgenic rice plant extracts could help stop the spread of HIV
August 18, 2018 - Hologic’s Cynosure division partners with Porter Instrument to distribute nitrous oxide and oxygen system
August 18, 2018 - Two thyroid medications recalled by FDA
August 18, 2018 - Forecast Sees Abnormal Heat Worldwide Through 2022
August 18, 2018 - Childhood absence epilepsy – Genetics Home Reference
August 18, 2018 - Fearing hard Brexit, UK drugmakers stockpile to protect lives
August 18, 2018 - Discovery may help broaden the scope of defenses against HPV
August 18, 2018 - When they start thinking green, they see green
August 18, 2018 - Scientists introduce microfluidics-based chip for manipulation and analysis of single cells
August 18, 2018 - Researchers design new way to grow nose cells for treating spinal cord injuries
August 18, 2018 - New light shed on relationship between calorie-burning fat and muscle function
August 18, 2018 - Surgery Saturday Instagram series takes you inside Stanford’s OR
August 18, 2018 - Researchers uncover surprising new role for inhibition in the cerebellum
August 18, 2018 - Children have better nutrition when they live near forests, global study shows
August 18, 2018 - OHSU professor conducts clinical trial with artificial pancreas using Xeris’ liquid glucagon
August 18, 2018 - HSS takes young patients with physical challenges on a surfing trip
August 18, 2018 - Study shows electronic health records leave doctors and patients unsatisfied
August 18, 2018 - Study uncovers mechanism that affects multiplication of dengue virus lineage
August 18, 2018 - Theravance Biopharma Reports Positive Top-Line Four-Week Data from Phase 2 Trial of TD-9855 for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension
August 18, 2018 - Animations prove effective in accurately measuring pain
August 18, 2018 - Three faculty members appointed to endowed positions | News Center
August 18, 2018 - New technique detects, measures, analyzes unevenly charged biomolecules
August 18, 2018 - Brief exposures to stressors can be beneficial to cells, shows study
August 18, 2018 - UTHealth-led survey shows much work remains to increase safety of e-health records
August 18, 2018 - Researchers use super-resolution microscope to unravel secrets of deadly Nipah virus
August 18, 2018 - Scientists identify pathways that reveal insights into mechanism of lung cancer etiology
August 18, 2018 - FDA approves marketing of brainsway deep transcranial magnetic stimulation system for OCD
August 17, 2018 - OUHSC gets $20 million grant to advance research and patient care for Oklahomans
August 17, 2018 - Sperm morphology differs depending on qualities of male bird
August 17, 2018 - Texas A&M researchers develop clay-based platform to grow blood vessels
August 17, 2018 - FDA Approves Expanded Indication for Orkambi (lumacaftor/ivacaftor) in Children Ages 2-5 Years
August 17, 2018 - Caring for Concussions | NIH News in Health
August 17, 2018 - Team explores diabetes drug’s ability to treat RSV infection
August 17, 2018 - New imaging technique can spot tuberculosis infection in an hour | News Center
August 17, 2018 - PolyU researchers design new self-fitting scaffold to induce bone regeneration
August 17, 2018 - CartiHeal and LSU Health successfully enroll first two patients in Agili-C IDE pivotal study
August 17, 2018 - Less-invasive options are slowing disease progression in glaucoma patients
August 17, 2018 - Researchers discover new promising target point for cancer and diabetes therapies
August 17, 2018 - Podcast: KHN’s ‘What the Health?’ See you in court!
August 17, 2018 - New mobile phone application enables early detection of cerebral ictus
August 17, 2018 - AJMC addresses role of community pharmacies in boosting adult vaccination rates
August 17, 2018 - UK’s leading sight loss charity invites applications from brightest minds in ophthalmic research
August 17, 2018 - Alternative devices can help when autoinjectors are unavailable
August 17, 2018 - Researchers produce artificial placenta model that closely resembles natural organ
August 17, 2018 - Study offers possibility of squelching a focal epilepsy seizure before symptoms appear
August 17, 2018 - FDA Alert: Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers
August 17, 2018 - New statewide program in North Dakota aims to stem opioid misuse
August 17, 2018 - Researchers discover why sepsis from a staph infection causes organ failure
August 17, 2018 - Stony Brook University’s new medical students start a transformative journey
August 17, 2018 - Revealed: The molecular mechanism underlying hypertrophic cardiomyopathy | News Center
August 17, 2018 - New modeling studies highlight urgent need for effective drug policy reforms to prevent HIV
August 17, 2018 - Research explores relationship between personal history of infectious fever and cancer risk
August 17, 2018 - Study finds rise in cases of progressive massive fibrosis among U.S. coal miners
August 17, 2018 - NEDBELS project examines impact of neurodiversity concept on legal systems
August 17, 2018 - Seeking solutions to treat scleroderma
August 17, 2018 - Statins may improve conditions of people with rare lung disease
August 17, 2018 - Study finds why some people with brain markers of Alzheimer’s never develop dementia
August 17, 2018 - Life Biosciences contributes $100,000 to fund its biomedical innovation course on aging
August 17, 2018 - Researchers develop a set of health outcome measures for children with complex medical situations
August 17, 2018 - Many Americans Not Being Assessed for Depression
August 17, 2018 - Scientists report setbacks in quest for AIDS cure
August 17, 2018 - Christopher Gardner busts myths about milk | News Center
FDA Approves Tibsovo (ivosidenib) for Relapsed or Refractory Acute Myeloid Leukemia with an IDH1 Mutation

FDA Approves Tibsovo (ivosidenib) for Relapsed or Refractory Acute Myeloid Leukemia with an IDH1 Mutation

image_pdfDownload PDFimage_print

FDA Approves Tibsovo (ivosidenib) for Relapsed or Refractory Acute Myeloid Leukemia with an IDH1 Mutation

July 20, 2018 — The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (IDH1 inhibitors) and is approved for use with an FDA-approved companion diagnostic used to detect specific mutations in the IDH1 gene in patients with AML.

“Tibsovo is a targeted therapy that fills an unmet need for patients with relapsed or refractory AML who have an IDH1 mutation,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The use of Tibsovo is associated with a complete remission in some patients and a reduction in the need for both red cell and platelet transfusions.”

AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of abnormal white blood cells in the bloodstream and bone marrow. The National Cancer Institute at the National Institutes of Health estimates that approximately 19,520 people will be diagnosed with AML this year; approximately 10,670 patients with AML will die of the disease in 2018.

Tibsovo is an isocitrate dehydrogenase-1 inhibitor that works by decreasing abnormal production of the oncometabolite 2-hydroxyglutarate (2-HG), leading to differentiation of malignant cells. If the IDH1 mutation is detected in blood or bone marrow samples using an FDA-approved test, the patient may be eligible for treatment with Tibsovo. Today the agency also approved the RealTime IDH1 Assay, a companion diagnostic that can be used to detect this mutation.

The efficacy of Tibsovo was studied in a single-arm trial of 174 adult patients with relapsed or refractory AML with an IDH1 mutation. The trial measured the percentage of patients with no evidence of disease and full recovery of blood counts after treatment (complete remission or CR), as well as patients with no evidence of disease and partial recovery of blood counts after treatment (complete remission with partial hematologic recovery or CRh). With a median follow-up of 8.3 months, 32.8 percent of patients experienced a CR orCRh that lasted a median 8.2 months. Of the 110 patients who required transfusions of blood or platelets due to AML at the start of the study, 37 percent went at least 56 days without requiring a transfusion after treatment with Tibsovo.

Common side effects of Tibsovo include fatigue, increase in white blood cells, joint pain, diarrhea, shortness of breath, swelling in the arms or legs, nausea, pain or sores in the mouth or throat, irregular heartbeat (QT prolongation), rash, fever, cough and constipation. Women who are breastfeeding should not take Tibsovo because it may cause harm to a newborn baby.

Tibsovo must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. The prescribing information for Tibsovo includes a boxed warning that an adverse reaction known as differentiation syndrome can occur and can be fatal if not treated. Signs and symptoms of differentiation syndrome may include fever, difficulty breathing (dyspnea), acute respiratory distress, inflammation in the lungs (radiographic pulmonary infiltrates), fluid around the lungs or heart (pleural or pericardial effusions), rapid weight gain, swelling (peripheral edema) or liver (hepatic), kidney (renal) or multi-organ dysfunction. At first suspicion of symptoms, doctors should treat patients with corticosteroids and monitor patients closely until symptoms go away.

Other serious warnings include a QT prolongation, which can be life-threatening. Electrical activity of the heart should be tested with an electrocardiogram during treatment. Guillain-Barré syndrome, a rare neurological disorder in which the body’s immune system mistakenly attacks part of its peripheral nervous system, has happened in people treated with Tibsovo, so patients should be monitored for nervous system problems.

The FDA granted this application Fast Track and Priority Review designations. Tibsovo also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

The FDA granted the approval of Tibsovo to Agios Pharmaceuticals, Inc. The FDA granted the approval of the RealTime IDH1 Assay to Abbott Laboratories.

Source: FDA

Posted: July 2018

Related Articles:

Tibsovo (ivosidenib) FDA Approval History

Tagged with:

About author

Related Articles