Breaking News
October 16, 2018 - Health Highlights: Oct. 12, 2018
October 16, 2018 - Study holds promise for new pediatric brain tumor treatment
October 16, 2018 - Patient advocate uses MRI scans to create art and spark conversations about life with illness
October 16, 2018 - Fish oil based diets may suppress growth and spread of breast cancer cells
October 16, 2018 - Number of VHA facilities offering acupuncture has increased rapidly
October 16, 2018 - Influential Leapfrog Group jumps in to rate 5,600 surgery centers
October 16, 2018 - HIV-infected infants more likely to acquire congenital cytomegalovirus infection
October 16, 2018 - Study pinpoints new marker that can predict Crohn’s disease subtype
October 16, 2018 - Simple procedure could be efficacious intervention for failed back surgery
October 16, 2018 - New research identifies modifiable dementia risk factor in elderly people
October 16, 2018 - Zebrafish study uncovers molecular ‘brake’ that helps control eye lens development
October 16, 2018 - Overlapping copy number variations underlie autism and schizophrenia in Japanese patients
October 16, 2018 - Majority of Americans’ ancestry can be traced through existing DNA databases
October 16, 2018 - Patients coerced into mental health care less likely to perceive treatment as effective
October 16, 2018 - Interactive robot helps older people exercise and detects underlying health problems
October 16, 2018 - What you need to know about autism spectrum disorder
October 16, 2018 - Antidepressants can be used to treat Alzheimer’s disease
October 16, 2018 - Study uncovers important role of PRMT1 in dilated cardiomyopathy
October 16, 2018 - Nutritional quality of breakfast linked to cardiovascular and metabolic risk factors in children
October 16, 2018 - Study uses novel approach to investigate genetic origins of mental illnesses
October 16, 2018 - Scientists develop dual anthrax-plague vaccine
October 16, 2018 - Poor Outcomes for Hispanic Infants With Congenital Heart Dz
October 16, 2018 - Global study finds youngest in class more likely to be diagnosed with ADHD
October 16, 2018 - Researchers sequence two selfish genes in the fungus Neurospora intermedia
October 16, 2018 - Survey results highlight the need for better communication between patients and HCPs about bacterial vaginosis
October 16, 2018 - Researchers develop fibrin-targeting immunotherapy to protect against neurodegeneration
October 16, 2018 - Researchers create open access database on healthy immunity
October 16, 2018 - Rice University chemist wins big award to study small surfaces
October 16, 2018 - Study finds 43% drop in stroke rate
October 16, 2018 - Researchers identify basic relationships of cell cycle and cellular senescence in the placenta
October 16, 2018 - UA professor receives NSF grant to develop antifouling materials for medical implants
October 16, 2018 - Obesity Doubles Odds for Colon Cancer in Younger Women
October 16, 2018 - Adults with ADHD not constrained in creativity
October 16, 2018 - Raising visibility for people and students with chronic illness and disability
October 16, 2018 - Allele awarded NIH grant to develop nanoantibody therapies for treatment of sepsis
October 16, 2018 - Only 59% of young adults undergoing surgery are fluid responsive
October 16, 2018 - Research points to potential new treatment for hearing loss
October 16, 2018 - MDI Biological Laboratory receives $1.2 million SEPA grant to promote data literacy
October 16, 2018 - Vast majority of dementia cases may arise from spontaneous genetic errors
October 16, 2018 - New project aims to deliver fast, effective treatment for autoimmune rheumatic diseases
October 16, 2018 - Study identifies molecular switch that controls fate of milk-producing breast cells
October 16, 2018 - Research shows diet has little influence on precursor to gout
October 16, 2018 - “Without Dr. Shumway doing his miracle work, three generations would not be here”: A Stanford heart transplant patient’s story
October 16, 2018 - Non-invasive brain stimulation sheds light on neurobiology underlying implicit bias
October 16, 2018 - Researchers demonstrate integrated technique to control production of cell therapeutics
October 16, 2018 - Breast tomosynthesis detects 34% more tumors than traditional mammography
October 16, 2018 - Rhode Island Hospital, Brown receive $800,000 grant to keep up fight against opioid epidemic
October 16, 2018 - UVA partners with health systems in AVIA network’s Medicaid Transformation Project
October 16, 2018 - Trevena Announces Oliceridine FDA Advisory Committee Meeting Outcome
October 16, 2018 - Study reveals early warning signs of heart problems in patients with newly diagnosed lupus
October 16, 2018 - Connecting the dots of Alzheimer’s disease
October 16, 2018 - New publication offers evidence-based content for global breast imaging medical community
October 16, 2018 - ‘EinsteinVision’ that improves hand-eye coordination of surgeons introduced at Harefield Hospital
October 16, 2018 - WRAIR clinical study evaluates safety and immunogenicity of Marburg vaccine
October 16, 2018 - Ketamine can be considered as alternative to opioids for short-term pain control in ED
October 16, 2018 - Endurance exercise training beneficially alters gut microbiota composition
October 15, 2018 - FDA Approves Yutiq (fluocinolone acetonide intravitreal implant) for Chronic Non-Infectious Posterior Segment Uveitis
October 15, 2018 - Birthing Options for Full-Term Pregnancy
October 15, 2018 - Stressed, toxic, zombie cells seen for first time in Alzheimer’s
October 15, 2018 - Concussion researchers study head motion in high school football hits | News Center
October 15, 2018 - Neuropsychiatric symptoms related to earliest stages of Alzheimer’s brain pathology
October 15, 2018 - Neck collar device may help protect the brain of female high school soccer players
October 15, 2018 - Research reveals how the inner ear processes speech
October 15, 2018 - Many parents still skeptical about safety and effectiveness of flu shot, survey finds
October 15, 2018 - Payer Policies May Discourage Non-Pharma Tx for Low Back Pain
October 15, 2018 - Exercise may delay cognitive decline in people with rare Alzheimer’s disease
October 15, 2018 - Researchers modify CRISPR to reorganize genome | News Center
October 15, 2018 - Innovative brain tumor operation set to tailor to patients’ needs
October 15, 2018 - Findings offer new insight into early changes that occur during AD pathology
October 15, 2018 - Neurons regulating reproductive hormone release have different activity in epileptic mice
October 15, 2018 - More parents are concerned about taking babies swimming in public pools
October 15, 2018 - Health Tip: Know the Risk Factors for Lower Back Pain
October 15, 2018 - Study shows cigarillo flavors enhanced by high-intensity sweeteners
October 15, 2018 - Study traces hospital-acquired bloodstream infections to patients’ own bodies | News Center
October 15, 2018 - Abnormal vision in childhood can affect development of brain areas responsible for attention
October 15, 2018 - Study highlights need for increased support for alcohol-related liver disease patients
October 15, 2018 - Color-changing contact lens could help doctors to monitor eye disease medications
October 15, 2018 - Tobacco heating products cause less staining to teeth than conventional cigarettes
October 15, 2018 - Young adults who are obese can expect to lose up to 10 years in life expectancy
October 15, 2018 - Scientists uncover how proteins meet on the cell membrane
CHMP grants positive opinion for VENCLYXTO plus rituximab for treating relapsed/refractory CLL

CHMP grants positive opinion for VENCLYXTO plus rituximab for treating relapsed/refractory CLL

image_pdfDownload PDFimage_print

AbbVie, a research-based global biopharmaceutical company, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for VENCLYXTO® (venetoclax tablets) in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) who have received at least one prior therapy. The positive CHMP opinion is a scientific recommendation for marketing authorization to the European Commission (EC), which will deliver its final decision, valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

In 2016, VENCLYXTO was approved by the EC as a monotherapy for the treatment of R/R CLL in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, and for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor. If approved by the EC, VENCLYXTO plus rituximab could be prescribed to a broader patient population with R/R CLL than the currently approved indication for VENCLYXTO monotherapy in the EU.

“This positive CHMP opinion is one important step forward as AbbVie continues to further the research and development of novel medicines with the potential to transform the standard of care in blood cancers,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “The combination of VENCLYXTO with rituximab has the potential to give patients with relapsed/refractory chronic lymphocytic leukemia a chance to live longer without their disease progressing, and to stop treatment after their two-year course.”

The CHMP positive opinion is based on results from the MURANO Phase 3 clinical trial, which evaluated the efficacy and safety of VENCLYXTO in combination with rituximab compared with bendamustine in combination with rituximab. At the time of the primary analysis, the trial demonstrated a statistically significant improvement in investigator-assessed progression-free survival (PFS; the time on treatment without disease progression or death) for patients who received VENCLYXTO plus rituximab compared with bendamustine plus rituximab.

In the MURANO clinical trial, undetectable minimal residual disease (uMRD), also known as minimal residual disease negativity (MRD-) was a secondary endpoint assessed at the end of combination therapy (nine-month assessment). The majority of patients in the trial who received VENCLYXTO plus rituximab achieved uMRD in the peripheral blood. Undetectable minimal residual disease, is defined as the presence of less than one CLL cell in 10,000 white blood cells remaining in the blood or bone marrow following treatment.

“The venetoclax plus rituximab combination has the potential to be truly transformative for patients with relapsed/refractory CLL,” said Prof. John Seymour, MBBS, Ph.D., lead investigator of the MURANO trial and Director of Cancer Medicine at the Peter MacCallum Cancer Centre & Royal Melbourne Hospital in Australia. “The progression-free survival observed in the MURANO trial, and the fixed duration of treatment that may allow patients to stop treatment, are encouraging developments with the potential to advance the care and management of patients with relapsed/refractory CLL.”

CLL is a slow-growing form of leukemia, or blood cancer, in which too many immature lymphocytes (a type of white blood cell) are found predominantly in the blood and bone marrow. CLL accounts for approximately one third of new leukemia diagnoses.

VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

Source:

https://news.abbvie.com/news/press-releases/abbvie-receives-positive-chmp-opinion-for-novel-chemotherapy-free-combination-venclyxto-venetoclax-tablets-with-rituximab-as-treatment-with-fixed-duration-for-patients-with-chronic-lymphocytic-leukemia-who-have-received-at-least-one-prior-therapy.htm

Tagged with:

About author

Related Articles