Breaking News
May 3, 2019 - Vaping and Smoking May Signal Greater Motivation to Quit
May 3, 2019 - Dementia looks different in brains of Hispanics
May 3, 2019 - Short-Staffed Nursing Homes See Drop In Medicare Ratings
May 3, 2019 - Study of teens with eating disorders explores how substance users differ from non-substance users
May 3, 2019 - Scientists develop new video game that may help in the study of Alzheimer’s
May 3, 2019 - Arc Bio introduces Galileo Pathogen Solution product line at ASM Clinical Virology Symposium
May 3, 2019 - Cornell University study uncovers relationship between starch digestion gene and gut bacteria
May 3, 2019 - How to Safely Use Glucose Meters and Test Strips for Diabetes
May 3, 2019 - Anti-inflammatory drugs ineffective for prevention of Alzheimer’s disease
May 3, 2019 - Study tracks Pennsylvania’s oil and gas waste-disposal practices
May 3, 2019 - Creating a better radiation diagnostic test for astronauts
May 3, 2019 - Vegans are often deficient in these four nutrients
May 3, 2019 - PPDC announces seed grants to develop medical devices for children
May 3, 2019 - Study maps out the frequency and impact of water polo head injuries
May 3, 2019 - Research on Reddit identifies risks associated with unproven treatments for opioid addiction
May 3, 2019 - Good smells may help ease tobacco cravings
May 3, 2019 - Medical financial hardship found to be very common among people in the United States
May 3, 2019 - Researchers develop multimodal system for personalized post-stroke rehabilitation
May 3, 2019 - Study shows significant mortality benefit with CABG over percutaneous coronary intervention
May 3, 2019 - Will gene-editing of human embryos ever be justifiable?
May 3, 2019 - FDA Approves Dengvaxia (dengue vaccine) for the Prevention of Dengue Disease in Endemic Regions
May 3, 2019 - Why Tonsillitis Keeps Coming Back
May 3, 2019 - Fighting the opioid epidemic with data
May 3, 2019 - Maggot sausages may soon be a reality
May 3, 2019 - Deletion of ATDC gene prevents development of pancreatic cancer in mice
May 2, 2019 - Targeted Therapy Promising for Rare Hematologic Cancer
May 2, 2019 - Alzheimer’s disease is a ‘double-prion disorder,’ study shows
May 2, 2019 - Reservoir bugs: How one bacterial menace makes its home in the human stomach
May 2, 2019 - Clinical, Admin Staff From Cardiology Get Sneak Peek at Epic
May 2, 2019 - Depression increases hospital use and mortality in children
May 2, 2019 - Vicon and NOC support CURE International to create first gait lab in Ethiopia
May 2, 2019 - Researchers use 3D printer to make paper organs
May 2, 2019 - Viral infection in utero associated with behavioral abnormalities in offspring
May 2, 2019 - U.S. Teen Opioid Deaths Soaring
May 2, 2019 - Opioid distribution data should be public
May 2, 2019 - In the Spotlight: “I’m learning every single day”
May 2, 2019 - 2019 Schaefer Scholars Announced
May 2, 2019 - Podcast: KHN’s ‘What The Health?’ Bye-Bye, ACA, And Hello ‘Medicare-For-All’?
May 2, 2019 - Study describes new viral molecular evasion mechanism used by cytomegalovirus
May 2, 2019 - SLU study suggests a more equitable way for Medicare reimbursement
May 2, 2019 - Scientists discover first gene involved in lower urinary tract obstruction
May 2, 2019 - Researchers identify 34 genes associated with increased risk of ovarian cancer
May 2, 2019 - Many low-income infants receive formula in the first few days of life, finds study
May 2, 2019 - Global study finds high success rate for hip and knee replacements
May 2, 2019 - Taking depression seriously: What is it?
May 2, 2019 - With Head Injuries Mounting, Will Cities Put Their Feet Down On E-Scooters?
May 2, 2019 - Scientists develop small fluorophores for tracking metabolites in living cells
May 2, 2019 - Study casts new light into how mothers’ and babies’ genes influence birth weight
May 2, 2019 - Researchers uncover new brain mechanisms regulating body weight
May 2, 2019 - Organ-on-chip systems offered to Asia-Pacific regions by Sydney’s AXT
May 2, 2019 - Adoption of new rules drops readmission penalties against safety net hospitals
May 2, 2019 - Kids and teens who consume zero-calorie sweetened beverages do not save calories
May 2, 2019 - Improved procedure for cancer-related erectile dysfunction
May 2, 2019 - Hormone may improve social behavior in autism
May 2, 2019 - Alzheimer’s disease may be caused by infectious proteins called prions
May 2, 2019 - Even Doctors Can’t Navigate Our ‘Broken Health Care System’
May 2, 2019 - Study looks at the impact on criminal persistence of head injuries
May 2, 2019 - Honey ‘as high in sugars as table sugar’
May 2, 2019 - Innovations to U.S. food system could help consumers in choosing healthy foods
May 2, 2019 - FDA Approves Mavyret (glecaprevir and pibrentasvir) as First Treatment for All Genotypes of Hepatitis C in Pediatric Patients
May 2, 2019 - Women underreport prevalence and intensity of their own snoring
May 2, 2019 - Concussion summit focuses on science behind brain injury
May 2, 2019 - Booker’s Argument For Environmental Justice Stays Within The Lines
May 2, 2019 - Cornell research explains increased metastatic cancer risk in diabetics
May 2, 2019 - Mount Sinai study provides fresh insights into cellular pathways that cause cancer
May 2, 2019 - Researchers to study link between prenatal pesticide exposures and childhood ADHD
May 2, 2019 - CoGEN Congress 2019: Speakers’ overviews
May 2, 2019 - A new strategy for managing diabetic macular edema in people with good vision
May 2, 2019 - Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL) Due to Lack of Sterility Assurance
May 2, 2019 - Screen time associated with behavioral problems in preschoolers
May 2, 2019 - Hormone reduces social impairment in kids with autism | News Center
May 2, 2019 - Researchers synthesize peroxidase-mimicking nanozyme with low cost and superior catalytic activity
May 2, 2019 - Study results of a potential drug to treat Type 2 diabetes in children announced
May 2, 2019 - Multigene test helps doctors to make effective treatment decisions for breast cancer patients
May 2, 2019 - UNC School of Medicine initiative providing unique care to dementia patients
May 2, 2019 - Nestlé Health Science and VHP join forces to launch innovative COPES program for cancer patients
May 2, 2019 - Study examines how our brain generates consciousness and loses it during anesthesia
May 2, 2019 - Transition Support Program May Aid Young Adults With Type 1 Diabetes
May 2, 2019 - Study shows how neutrophils exacerbate atherosclerosis by inducing smooth muscle-cell death
May 2, 2019 - Research reveals complexity of how we make decisions
FDA approves new combination therapy for acute myeloid leukemia

FDA approves new combination therapy for acute myeloid leukemia

Older patients with acute myeloid leukemia (AML) often aren’t healthy enough to receive intensive chemotherapy, and gentler treatments aren’t very effective in treating this aggressive blood cancer.

But a new option – a combination of a standard drug and the novel agent venetoclax – has been granted accelerated approval by the Food and Drug Administration for such patients after a large, multicenter phase 1 clinical trial showed the combination had “promising efficacy” and was well tolerated in older AML patients.

“I think it’s likely to become a standard for patients in this situation who have AML but can’t tolerate induction therapy” with harsher chemotherapy regimens, said Anthony Letai, MD, PhD, a medical oncologist at Dana-Farber Cancer Institute. Letai, who has carried out key research on inhibition of the BCL-2 pathway, leading to drugs like venetoclax (Venclexta), is corresponding author of a recent report in Blood on the results of an industry-sponsored phase 1 clinical trial.

The FDA approval is for use of venetoclax in combination with azacitidine, decitabine, or low-dose cytarabine for treatment of patients with newly diagnosed AML who are 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

The median age of people diagnosed with AML is 67. Patients who are considered fit enough are treated with “induction” therapy aimed at putting the disease in remission, followed by “consolidation” therapy with additional chemotherapy or a stem cell transplant. If successful, that two-step process can cure up to 40 percent of patients, said Letai. “But only a minority of patients are eligible to begin with” because of advanced age or because they have other conditions, such as heart disease, that increases their risk of death.

As a compromise, these patients may be treated with lower-intensity drugs called hypomethylating agents, such as azacitidine and decitabine. Letai said these drugs are “relatively nontoxic, but not that effective.” They induce remissions only in about 20 percent of patients, and often require several months of treatment to achieve remission, he said. They are rarely curative, with patients having a median survival of less than a year.

In an effort to improve this situation, the clinical trial paired hypomethylating agents with venetoclax, the first of a new class of targeted drugs called BCL-2 inhibitors that destroy cancer cells by attacking BCL-2, a “survival protein” they rely on to survive and multiply. Important advances in understanding BCL-2’s role in cancer and how it could be blocked to kill cancer cells was conducted in Letai’s Dana-Farber laboratory. Venetoclax, sold under the name Venclexta, was first approved in 2016 to treat certain patients with chronic lymphocytic leukemia (CLL) and its use has been expanded in those patients more recently.

Letai and Marina Konopleva, MD, PhD, of MD Anderson Cancer Center, in collaboration with researchers at the pharmaceutical company AbbVie, focused on how inhibiting BCL-2 in AML might be a new approach to treating the disease. Initial human trials with a BCL-2 inhibitor showed that as a single agent it had activity in patients with AML, but the effects weren’t robust.

Still, the rationale was promising. So, the researchers and AbbVie scientists created a clinical trial combining venetoclax at varying dosages with a hypomethylating drug – azacitidine or decitabine. The report in Blood demonstrates that the pairing of the two drugs is safe and relatively tolerable in AML patients not healthy enough for standard induction chemotherapy.

The trial included 145 patients ages 65 and above who received venetoclax and decitabine or azacytidine as initial therapy. The overall response rate – complete responses plus complete responses with incomplete blood count recovery – was 67 percent. Patients who were older (75 years or above) and who had poor-risk pathological features in their cancer cells had a CR rate of 60 percent and a CR plus CRi rate of 65 percent.

The median overall survival has not been reached for patients receiving 400 mg of venetoclax. For patients receiving all dosages, median overall survival was 17.5 months.

Also encouraging, said Letai, was that responses occurred more rapidly with the combination therapy than is typical with hypomethylating agents alone.

A phase 3 trial that is underway is comparing venetoclax and azacytidine with azacytidine as a single agent.

This trial was supported by AbbVie and Genentech, which are jointly developing venetoclax.

The FDA approval “marks a significant advance for people with acute myeloid leukemia, a highly aggressive and difficult-to-treat blood cancer,” said Sandra Horning, MD, chief medical officer at Genentech.

Source:

https://www.dana-farber.org/newsroom/news-releases/2018/venetoclax-combination-approved-for-elderly-aml/

Tagged with:

About author

Related Articles