Breaking News
September 26, 2018 - Fewer American Teens Having Sex, Most Using Birth Control
September 26, 2018 - We are predisposed to forgive, new research suggests
September 26, 2018 - Insomnia Exacts Heavy Toll on Quality of Life
September 26, 2018 - Clinical study shows efficacy, safety of novel drug-eluting stent with improved radiographic visibility
September 26, 2018 - Cytox, AIBL announce expanded agreement to assess genetic risk for Alzheimer’s
September 26, 2018 - Study finds persistent rate of lawnmower injury-related emergency department visits
September 26, 2018 - Researchers find molecule that halts, reverts neurodegeneration caused by Parkinson’s disease
September 26, 2018 - Novartis announces winners of 2018 eXcellence in Ophthalmology Vision Award
September 26, 2018 - New spinout company to tackle drug-resistant infections with novel antibiotics
September 26, 2018 - In depression the brain region for stress control is larger
September 26, 2018 - Smuggling RNA into cells can activate the immune system to fight cancer
September 26, 2018 - Special Focus Issue takes wide view of complementary and integrative medicine in cancer
September 26, 2018 - Researchers now confirm that genome duplication drives evolution of species
September 25, 2018 - Study provides evidence of beta lactamase producing, antimicrobial resistant E. coli in U.S. retail meat
September 25, 2018 - UCI study finds new cause of cerebral microbleeds
September 25, 2018 - Researchers propose mechanism by which ASTN2 protein defects lead to brain disorders
September 25, 2018 - Chinese and German researchers to cooperate more closely in future for better food
September 25, 2018 - Recent study helps predict probability of pregnant mothers to have child with autism
September 25, 2018 - New online, sound matching tool offers tinnitus sufferers potential treatment options
September 25, 2018 - UC Davis researchers take critical step in developing more effective Salmonella vaccine
September 25, 2018 - Antibiotics best paediatric treatment for children’s chronic wet cough
September 25, 2018 - Looking beyond opioids: Stanford pain psychologist briefs Congress
September 25, 2018 - Organs actively fighting back against autoimmune diseases, finds study
September 25, 2018 - Lancaster professor aims to understand how genes affect smoking cessation
September 25, 2018 - Human-oriented perspective needed to better understand Parkinson’s disease
September 25, 2018 - Physical activity may have beneficial effects for people with rare Alzheimer’s disease
September 25, 2018 - FDA Updates on Valsartan Recalls
September 25, 2018 - 3-D-printed tracheal splints used in groundbreaking pediatric surgery
September 25, 2018 - Who is the designated driver, or proxy, for your health decisions?
September 25, 2018 - New chemo-optogenetic method enables multi-directional activity control of cellular processes
September 25, 2018 - Study explores link between genetic predisposition to Alzheimer’s and cardiometabolic risk factors
September 25, 2018 - NeoTract presents new clinical data from studies of UroLift System for patients with BPH
September 25, 2018 - Patients with paralysis manage to walk thanks to new technology
September 25, 2018 - Statins Improve Long-Term Survival After AAA Repair
September 25, 2018 - Novel brain network linked to chronic pain in Parkinson’s disease
September 25, 2018 - Researchers reassess negative pressure wound therapy as its benefit and harm remain unclear
September 25, 2018 - Older adults with ‘fall plan of care’ less likely to suffer fall-related hospitalizations
September 25, 2018 - FDA lifts partial clinical hold that paused enrollment of new patients in tazemetosta clinical trials
September 25, 2018 - IME Medical Electrospinning establishes state-of-the-art manufacturing lab facilities
September 25, 2018 - Phase 1 and 2 clinical trials of entrectinib drug in ROS1-positive NSCLC show promising results
September 25, 2018 - How to Protect Your Eyesight
September 25, 2018 - Novel approach allows researchers to define how cells in the retina respond to diabetes
September 25, 2018 - Columbia University announces winners of 2018 Louisa Gross Horwitz Prize
September 25, 2018 - New model enables anyone to run powerful simulations, complex calculations easily
September 25, 2018 - Clinical trial investigators found non-compliant with requirement to report results on EU register
September 25, 2018 - Study analyzes quality of protein supplements in function of source, treatment and storage
September 25, 2018 - FDA grants Orphan Drug Designation to Myelo001 for treatment of Acute Radiation Syndrome
September 25, 2018 - U.S. Alzheimer’s Cases to Nearly Triple by 2060
September 25, 2018 - Improving cell replacement therapy for Parkinson’s disease
September 25, 2018 - Genervon reports new findings that drug candidate GM6 attenuates Alzheimer’s disease in mice model
September 25, 2018 - FDA approves new 5 mm diameter drug-eluting stent from Cook Medical
September 25, 2018 - New $17.8 million grant ensures USC at forefront of research on tobacco-related health risks
September 25, 2018 - Researchers analyze response to combination immunotherapy for patients with rare skin cancer
September 25, 2018 - Study sheds light on how brain protein may be involved neurodevelopmental disorders
September 25, 2018 - Where to draw the line on incentives
September 25, 2018 - Solid fuel use linked with increased risk of hospitalization or death from respiratory diseases
September 25, 2018 - ‘Trouble Brewing’ report highlights steps that governments can take to reduce alcohol-related harms
September 25, 2018 - Recurrence risk of VTE appears similar for patients with cancer and those with unprovoked VTE
September 25, 2018 - Global leaders must make bold commitments at first-ever UN tuberculosis summit
September 25, 2018 - Brief sleep intervention works long-term to prevent child obesity
September 25, 2018 - Vaping among kids and teens a growing concern
September 25, 2018 - Public launch of products and application solutions from Porvair Laboratory Division
September 25, 2018 - Harmful H. pylori may play a role in Parkinson’s disease
September 25, 2018 - Researchers develop way to measure different types of fear of falling in patients with Parkinson’s
September 25, 2018 - Fracture causes bone density losses throughout the body
September 25, 2018 - Researchers highlight potential therapy for treating rare, deadly blood-clotting disorder
September 25, 2018 - Hybrid theranostic complex shows high therapeutic efficacy against tumor cells
September 25, 2018 - FDA Issues Statement Reaffirming the Positive Benefit-Risk Profile of Nuplazid (pimavanserin) for Patients with Hallucinations and Delusions Associated with Parkinson’s Disease Psychosis
September 25, 2018 - Toxicological evaluation and dosimetry estimation of potential PET radiotracer
September 25, 2018 - 5 obstacles parents commonly face in child obesity treatment and how to overcome them
September 25, 2018 - Immunologist to study how Chikungunya causes devastating effects in older adults
September 25, 2018 - Rural borderland communities vulnerable to high stress impacting mental and physical health
September 25, 2018 - SNMMI announces recipients of 2018-2020 Wagner-Torizuka Fellowship
September 25, 2018 - Common painkiller not effective in controlling chronic pain after traumatic nerve injury
September 25, 2018 - New therapeutic vaccine helps immune cells fight HPV-related head and neck cancer
September 25, 2018 - Environmentally-induced gene activity influences IQ test performance
September 25, 2018 - Biogen and Eisai announce results of LTE Phase 1b study of aducanumab for treating MCI
September 25, 2018 - FDA Approves Copiktra (duvelisib) Capsules for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Follicular Lymphoma
September 25, 2018 - Medical device company settles US case over false claims
September 25, 2018 - Trying to get answers: One woman’s quest for a diagnosis
FDA Expands Approval of Imfinzi (durvalumab) to Reduce the Risk of Non-Small Cell Lung Cancer Progressing

FDA Expands Approval of Imfinzi (durvalumab) to Reduce the Risk of Non-Small Cell Lung Cancer Progressing

image_pdfDownload PDFimage_print

February 16, 2018 — The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation).

“This is the first treatment approved for stage III unresectable non-small cell lung cancer to reduce the risk of the cancer progressing, when the cancer has not worsened after chemoradiation,” 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. “For patients with stage III lung cancer that cannot be removed surgically, the current approach to prevent progression is chemoradiation. Although a small number of patients may be cured with the chemoradiation, the cancer may eventually progress. Patients now have an approved therapy that has been shown to keep the cancer from progressing for a longer time after chemoradiation.”

Lung cancer is the leading cause of cancer death in the United States, with an estimated 222,500 new diagnoses and 155,870 deaths in 2017, according to the National Cancer Institute at the National Institutes of Health. The most common type of lung cancer, NSCLC occurs when cancer cells form in the tissues of the lung. Stage III NSCLC means tumors have spread to nearby lymph nodes or into other parts of the body near the lungs.

Imfinzi targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). By blocking these interactions, Imfinzi may help the body’s immune system attack cancer cells. Imfinzi was previously granted accelerated approval in 2017 for the treatment of certain patients with locally advanced or metastatic bladder cancer.

The approval of Imfinzi for the treatment of stage III, unresectable NSCLC was based on a randomized trial of 713 patients whose cancer had not progressed after completing chemotherapy and radiation. The trial measured the length of time the tumors did not have significant growth after starting treatment with Imfinzi or a placebo (progression-free survival). The median progression-free survival for patients taking Imfinzi was 16.8 months compared to 5.6 months for patients receiving a placebo. In addition, the sponsor has agreed to a post-marketing commitment to provide additional information from their study to the FDA about how long patients lived following treatment with Imfinzi after chemotherapy and radiation (overall survival).

Common side effects of Imfinzi in patients with stage III unresectable NSCLC include cough, fatigue, inflammation in the lungs (pneumonitis/radiation pneumonitis), upper respiratory tract infections, difficulty breathing (dyspnea) and rash.

Serious risks of Imfinzi include immune-mediated side effects, where the body’s immune system attacks healthy cells or organs, such as the lungs (pneumonitis), liver (hepatitis), colon (colitis), hormone-producing glands (endocrinopathies) and kidneys (nephritis). Other serious side effects of Imfinzi include infection and infusion-related reactions. Imfinzi can cause harm to a developing fetus; women should be advised of the potential risk to the fetus and to use effective contraception.

The FDA granted this application Priority Review and Breakthrough Therapy designations.

The FDA granted the approval of Imfinzi to AstraZeneca.

Source: FDA

Posted: February 2018

Related Articles:

Imfinzi (durvalumab) FDA Approval History

Tagged with:

About author

Related Articles