Breaking News
August 20, 2018 - Study reveals how socioeconomic status affects racial, ethnic disparities in childhood cancer survival
August 20, 2018 - Brain tumors trap immune cells needed to fight cancer in the bone marrow, finds research
August 20, 2018 - Three factors that contribute to physician burnout
August 20, 2018 - Babies dependent on opioids need touch, not tech
August 20, 2018 - Understanding How Antibodies Shape the Gut Microbiome
August 20, 2018 - Cara Therapeutics Doses First Patient in Second Pivotal Phase 3 Efficacy Trial of Korsuva (CR845/difelikefalin) Injection in Hemodialysis Patients with Chronic Kidney Disease-Associated Pruritus
August 20, 2018 - Kidney transplant chains more effective in saving lives
August 20, 2018 - Study unravels cellular and molecular mechanisms behind dermal condensate formation
August 20, 2018 - New integrated gene logic-chips could have great value in medical care
August 20, 2018 - FDA Advisory Committee Recommends Approval of Paratek’s Omadacycline
August 20, 2018 - Total, open repairs decline for abdominal aortic aneurysms
August 20, 2018 - Novel system can pinpoint ingestible implants inside the body using wireless signals
August 20, 2018 - Infection rates of high risk oral HPV in England found to be lower than expected
August 20, 2018 - Making robots as valuable and trustworthy assistants for medical therapies
August 20, 2018 - Patients with low-risk blood clots can be better treated at home than at hospital
August 20, 2018 - Passive smoking exposure among kids greatly increases COPD risk late in life
August 20, 2018 - Primary Care Provider Burnout Rate Low in Small Practices
August 20, 2018 - Discovery presents treatment hope for Alzheimer’s and other neurodegenerative diseases
August 20, 2018 - Stroke patients appear to receive better care at teaching hospitals with less chance of readmission
August 20, 2018 - Distinct origin of ADHD identified In children with history of traumatic brain injury
August 20, 2018 - AHA: Wildfire Smoke Threatens Health of Those Near and Far
August 20, 2018 - Here’s a mental health workout that’s as simple as ABC
August 20, 2018 - Newly discovered cytoskeleton utilized by cancer cells for survival
August 19, 2018 - Bifidobacteria supplement colonizes gut of breastfed infants
August 19, 2018 - Why patients with Alzheimer’s markers never develop the condition
August 19, 2018 - ACA’s Medicaid expansion associated with increase in prescriptions for opioid use disorder treatment
August 19, 2018 - Important factor may be missing in models used to predict spread of epidemics from climate change
August 19, 2018 - Indian-Americans have fewer sudden infant deaths, study finds
August 19, 2018 - Experts advise against universal genomic screening of newborns
August 19, 2018 - New trial to investigate whether weight loss before conception can make mom and baby healthier
August 19, 2018 - Sun Pharma Announces FDA Approval of Cequa (cyclosporine) Ophthalmic Solution to Treat Dry Eye Disease
August 19, 2018 - Researchers examining Parkinson’s resilience
August 19, 2018 - HPI, INTEGRIS and USPI enter into agreement to offer patients more choice, flexibility of care
August 19, 2018 - Researchers find mechanism that prepares brain to replicate repeated actions
August 19, 2018 - Those who are emotionally stable when young may remain the most stable as they age
August 19, 2018 - URI professor develops simpler and quicker method for detecting impurity in heparin
August 19, 2018 - Mayo Medical Laboratories and NDSC collaborate to develop new patient blood-management solution
August 19, 2018 - Insight into endocrine cancers and treatment options
August 19, 2018 - HPV Legislation Doesn’t Impact Teen Sexual Behaviors
August 19, 2018 - Exenatide treatment alleviated symptoms of depression in patients
August 19, 2018 - Tufts researchers win grant to study integration of genomic sequencing into neonatal care
August 19, 2018 - Novel finger-prick test can help prevent toxoplasmosis
August 19, 2018 - Cosmetic Procedures Boost Well-Being, Poll Shows
August 19, 2018 - Responsive parenting intervention results in lower BMIs through age three
August 19, 2018 - Anticancer drugs can help plants to battle infection
August 19, 2018 - Sunscreen from bathers releases significant quantities of polluting titanium dioxide into the sea
August 19, 2018 - Case Western Reserve gets three-year grant to enhance food systems in Cleveland neighborhoods
August 19, 2018 - Teenagers can thank their parents’ positive attitude for avoiding obesity
August 19, 2018 - Body mass index positively linked with blood pressure
August 19, 2018 - New tool fills gap in Small Molecules market
August 19, 2018 - Study compares survival outcomes in rural and urban cancer patients enrolled in clinical trials
August 19, 2018 - Researchers develop molecular matrix that delivers healing stem cells to injured elderly muscles
August 19, 2018 - Teva and Regeneron Announce Positive Topline Phase 3 Fasinumab Results in Patients with Chronic Pain from Osteoarthritis of the Knee or Hip
August 19, 2018 - New study pinpoints ways to improve quality of food and nutrition research
August 19, 2018 - Ology Bioservices wins $8.4 million worth agreement to manufacture anti-Ebola monoclonal antibody
August 19, 2018 - New CRISPR technology may help eliminate mutated gene sequence
August 19, 2018 - “Zombie gene” protects elephants from cancer finds study
August 19, 2018 - Study explores how many American cities protect the rights of employed breastfeeding mothers
August 19, 2018 - FDA Approves Lenvima (lenvatinib) for First-line Treatment of Unresectable Hepatocellular Carcinoma (HCC)
August 19, 2018 - Pain: Considering Complementary Approaches (eBook)
August 19, 2018 - Autoimmune response drives vision loss in glaucoma
August 19, 2018 - Tandem Diabetes Care introduces t:slim X2 Insulin Pump with Basal-IQ Technology in the US
August 19, 2018 - Innovative platform developed to destroy cancer cells
August 19, 2018 - Lowering pH inside tumor cells can slow down spread of cancer
August 19, 2018 - Biomarker predicts kidney cancer risk years before diagnosis
August 19, 2018 - Consequences of healthcare-associated infections go beyond patients’ physical health
August 19, 2018 - New drug- free, nanotechnology-based method detects and treats oral plaque
August 19, 2018 - Integration of Opioid, Infectious Disease Treatment Needed
August 19, 2018 - How eye disorders may have influenced the work of famous painters
August 18, 2018 - Blood biomarker could help predict kidney cancer up to five years prior to diagnosis
August 18, 2018 - Dartmouth scientists create more sustainable feed for aquaculture
August 18, 2018 - Immigrants Not a Burden on U.S. Health Care: Study
August 18, 2018 - Women who eat fast food take longer to become pregnant
August 18, 2018 - Most YouTube videos on plastic surgery are misleading marketing campaigns
August 18, 2018 - The essential guide to make your laboratory more sustainable
August 18, 2018 - Loyola Medicine offers scalp cooling treatment to reduce risk of chemotherapy hair loss
August 18, 2018 - Researchers describe promising strategy to remove melanoma’s most powerful defenses
August 18, 2018 - Women with polycystic ovary syndrome dissatisfied with medical care
August 18, 2018 - Research discoveries reveal insights behind neurological degeneration
August 18, 2018 - Researchers win multi-million Euro award to conduct research into liver disease
AbbVie submits supplemental NDA to FDA for venetoclax to treat acute myeloid leukemia

AbbVie submits supplemental NDA to FDA for venetoclax to treat acute myeloid leukemia

image_pdfDownload PDFimage_print

AbbVie, a research-based global biopharmaceutical company, today announced it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for venetoclax in combination with a hypomethylating agent (HMA) or in combination with low-dose cytarabine (LDAC) for the treatment of newly diagnosed patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.

The sNDA submission is based on investigational data from two studies: M14-358, a Phase 1b trial evaluating venetoclax in combination with an HMA (azacitidine or decitabine), and M14-387, a Phase 1/2 trial of venetoclax in combination with LDAC.

“AML is an especially lethal and aggressive form of blood cancer with limited advances in care in three decades and few treatment options for patients ineligible for intensive chemotherapy,” said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. “The data submitted to the FDA may potentially reshape how AML is treated. We look forward to working with the FDA and other health authorities during the review of these data.”

AML, primarily a disease of older patients, is the most common form of acute leukemia in adults, in which the bone marrow makes abnormal, immature types of white blood cells, red blood cells or platelets. AML is an aggressive blood cancer that, if left untreated, can progress quickly. In the U.S., it is estimated there will be 19,520 new cases and 10,670 deaths due to AML in 2018.

Approximately 27 percent of patients diagnosed with AML will survive five years or more. Disease recurrence occurs in most patients with AML within three years of diagnosis. Although few treatments are available, AML patients who are ineligible for intensive remission induction therapy may be treated with LDAC or HMAs. Only about one-third of AML patients older than age 60 are able to tolerate the intensive chemotherapy required to achieve optimal results. Median survival is five to 10 months in older AML patients who are ineligible for intensive chemotherapy.

The challenges of treating AML, including in older adults, is an ongoing topic of discussion among the medical community. Daniel Pollyea, M.D., director of Leukemia Services at University of Colorado Hospital, recently reflected on his experience treating patients with AML. “We have an incredible opportunity to develop better treatment options for people with AML. Still, right now every aspect of this disease represents an unmet need,” he said. For more on Dr. Pollyea’s perspective, please read “A Physicians View: Facing the Challenges of Treating AML in Older Adults.”

Venetoclax, an oral B-cell lymphoma-2 (BCL-2) inhibitor, has been granted four Breakthrough Therapy Designations (BTDs) from the FDA including for the combination of venetoclax with an HMA (azacitidine or decitabine) for treatment-naïve patients with AML who are ineligible to receive standard induction therapy (high-dose chemotherapy) and for the combination of venetoclax with LDAC for treatment-naïve patients with AML who are ineligible for intensive chemotherapy. According to the FDA, BTD is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

If approved in AML, venetoclax would be available for use in two blood cancers, chronic lymphocytic leukemia (CLL) and AML. Venetoclax recently received expanded approval in the U.S. for use alone or in combination with rituximab for the treatment of relapsed/refractory (R/R) CLL or small lymphocytic lymphoma (SLL) patients, with or without 17p deletion, who have received at least one prior therapy.

In addition to CLL and AML, venetoclax is being studied in a range of hematologic malignancies including multiple myeloma (MM), non-Hodgkin lymphoma (NHL) and myelodysplastic syndrome (MDS). Venetoclax is being developed by AbbVie and Roche and 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. Together, the companies are committed to BCL-2 research with venetoclax, which is currently being evaluated in clinical trials in several hematologic cancers.

Source:

https://news.abbvie.com/news/abbvie-announces-submission-supplemental-new-drug-application-to-us-fda-for-venetoclax-in-newly-diagnosed-acute-myeloid-leukemia-patients-ineligible-for-intensive-chemotherapy.htm

Tagged with:

About author

Related Articles