Breaking News
May 25, 2018 - Origami inspires researchers to develop new solution for tissue regeneration
May 25, 2018 - Melorheostosis – Genetics Home Reference
May 25, 2018 - Non-addictive pain medication changing therapy for substance use disorders
May 25, 2018 - Delayed lactate measurements in sepsis patients increase risk of in-hospital death
May 25, 2018 - Researchers identify novel epigenetic mutations as cause of neurodevelopmental, congenital disorders
May 25, 2018 - UD researchers examine connection between DNA replication in HPV and cancer
May 25, 2018 - Researchers identify neurons that play key role in aggressive behavior
May 25, 2018 - Researchers discover unexpected chemosensor pathway for predator odor-evoked innate fear behaviors
May 25, 2018 - Nearly one in three people know someone addicted to opioids
May 25, 2018 - New findings could help fine-tune treatment for cancer patients
May 25, 2018 - New cancer treatment approach targets specific sugar receptors
May 25, 2018 - Skin responsible for uptake of cancer-causing compounds during barbecuing than lungs
May 25, 2018 - Early-onset cannabis use linked to further drug abuse problems
May 25, 2018 - Covered California takes aim at hospital C-section rates
May 25, 2018 - FDA Approves Palynziq (pegvaliase-pqpz) for the Treatment of Adults with Phenylketonuria
May 25, 2018 - Arthritis Glossary
May 25, 2018 - Study links breast cancer to the body’s internal clock
May 25, 2018 - Strenuous exercise in teenage years may protect against height loss later in life
May 25, 2018 - FDA approves novel enzyme therapy for adults with rare and serious genetic disease
May 25, 2018 - New research project aims at developing effective interventions for kids with DLD
May 25, 2018 - Middlemen who save $$ on medicines — but maybe not for you
May 25, 2018 - Study sheds new light on sharp rise in fatal drug overdoses in recent years
May 25, 2018 - Students propose revision of listeriosis guidelines for safer pregnancy
May 25, 2018 - TNFi Exposure In Utero Does Not Up Serious Infection Risk
May 25, 2018 - Organization of cells in the inner ear enables the sense and sensitivity of hearing
May 25, 2018 - Yoga May Be Right Move Against Urinary Incontinence
May 25, 2018 - Drinking recommended amount of milk could protect obese children against metabolic syndrome
May 25, 2018 - New cytokine network can repair tissue damage in the intestine, study finds
May 25, 2018 - Lyme disease researcher dispels misconceptions about ticks and provides prevention tips
May 25, 2018 - Penn researchers find link between social media usage and underage drinking
May 25, 2018 - Unique nanotechnology method to simplify skin disease diagnosis
May 25, 2018 - Study reveals new protective mechanism for tumor cells in breast cancer
May 25, 2018 - FRAME Alternatives Laboratory chosen for major European liver research collaboration
May 25, 2018 - Study shows yogurt may dampen chronic inflammation linked to multiple diseases
May 25, 2018 - Invasive cancers that are born to be bad show detectable differences from harmless tumors
May 25, 2018 - Study identifies new mechanism involved in development of Lou Gehrig’s disease
May 25, 2018 - UAB professor receives award for malaria prevention study in pregnant women in Cameroon
May 25, 2018 - Study provides blueprint of how fruit flies can be used to screen potentially pathogenic human genes
May 25, 2018 - New drug-delivering nanoparticle could offer better way to treat brain tumors
May 25, 2018 - Kessler Foundation scientists compare two tests for assessing learning in individuals with MS
May 25, 2018 - Stroke Symptoms and Diagnosis (Beyond the Basics)
May 25, 2018 - Protein goes against the family to prevent cancer
May 25, 2018 - Drugmakers blamed for blocking generics have milked prices and cost U.S. billions
May 25, 2018 - Speakers announced for National Medicines Symposium 2018
May 25, 2018 - GSK Receives FDA Approval of Arnuity Ellipta for Asthma in Children From 5 Years of Age
May 25, 2018 - Pfizer settles kickback case related to copay assistance for $24m
May 25, 2018 - Nuclear pore functions are essential for T cell survival
May 25, 2018 - Study defines molecular basis to explain connection between mother’s nutrition and infant growth
May 24, 2018 - IHI hosts representatives to develop a national action plan for patient safety
May 24, 2018 - Zika detection breakthrough by University of Queensland
May 24, 2018 - FDA Alert: 95% Ethyl Alcohol Product by Ethanol Extraction: Recall
May 24, 2018 - New method allows scientists to study how HIV persists
May 24, 2018 - Study reveals rate of vertebral and non-vertebral fractures in children with leukemia
May 24, 2018 - Whey protein supplementation and physical activity aid women in improving body composition
May 24, 2018 - Seniors’ air pollution exposure linked to hospitalization for ARDS
May 24, 2018 - Home-based telehealth therapy program effective for stroke rehabilitation, shows study
May 24, 2018 - Addressing Parents’ HPV Vaccine Hesitancy Ups Vaccination Rates
May 24, 2018 - Opioid addiction treatment drug helps suppress HIV in former prisoners
May 24, 2018 - FDA warns against using teething remedies for babies
May 24, 2018 - Healthy lifestyle counseling program linked to reduced risk of developing cancers
May 24, 2018 - CU research sheds light on liver disease caused by intravenous nutrition
May 24, 2018 - Skin cream containing rapamycin reduces TSC-related facial tumors
May 24, 2018 - Suicide rates twice as high among black children finds new study
May 24, 2018 - Researchers find new method to treat severe asthma
May 24, 2018 - Scientists report new strategy for fighting bacteria
May 24, 2018 - South Asians living in the United States more likely to die of heart disease and stroke
May 24, 2018 - Health Tip: Why Get a Biopsy
May 24, 2018 - Metabolic Syndrome Prevalence by Race/Ethnicity and Sex in the United States, National Health and Nutrition Examination Survey, 1988–2012
May 24, 2018 - Motivation to move may start with being mindful
May 24, 2018 - Advanced genetics study of TB bacteria uncovers virulent ‘Beijing lineage’ strain among young adults
May 24, 2018 - Friends tend to have similar pain tolerance levels, study reveals
May 24, 2018 - International researchers succeed in stopping growth of mesothelioma in model animals
May 24, 2018 - Inactive people find high-intensity interval training to be as enjoyable as traditional exercise
May 24, 2018 - Now more of us can count on more time dodging the dementia bullet
May 24, 2018 - Scientists develop new test to predict woman’s risk of preterm birth
May 24, 2018 - Global healthcare access and quality improved from 2000-2016
May 24, 2018 - Virtual follow-up visits for hypertension care just as effective as in-person office visits
May 24, 2018 - New research reveals links between type 1 diabetes and mental health
May 24, 2018 - Antioxidant-enriched multivitamin may decrease respiratory illnesses in CF patients, finds study
May 24, 2018 - Antidepressant treatments increase risk of weight gain, study finds
FDA Approves New Indication for Gilotrif (afatinib) in EGFR Mutation-Positive NSCLC

FDA Approves New Indication for Gilotrif (afatinib) in EGFR Mutation-Positive NSCLC

image_pdfDownload PDFimage_print

Ridgefield, Conn., January 16, 2018 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif (afatinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test. The new label includes data on three additional EGFR mutations: L861Q, G719X and S768I. The FDA granted Priority Review status to Gilotrif in evaluating this application.

Gilotrif, an oral, once-daily tablet, was previously approved in the U.S. for the first-line treatment of patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations. In addition, Gilotrif is approved in the U.S. for patients with squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy.

“With this expanded indication for Gilotrif, NSCLC patients whose tumors have certain EGFR mutations now have an approved therapy that specifically targets these mutations,” said Sabine Luik, M.D., senior vice president of Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “This approval is a result of our company’s commitment to delivering meaningful treatment advances in areas with high unmet medical need and reflects the tireless efforts of physicians, researchers and patients who participated in our studies.”

The sNDA approval is based on a pooled analysis of three studies from the LUX-Lung clinical trial program (Phase II LUX-Lung 2 study and Phase III studies LUX-Lung 3 and LUX-Lung 6) that examined Gilotrif in NSCLC patients whose tumors have EGFR mutations, including L861Q, G719X or S768I. This analysis showed that Gilotrif was active in these EGFR mutations based on objective response rate, duration of response, disease control, progression-free survival and overall survival.

“Compared with other EGFR mutations, L861Q, G719X or S768I substitution mutations are associated with a poorer prognosis and limited treatment options,” said Edward Kim, M.D., Levine Cancer Institute, Carolinas HealthCare System. “The approval of Gilotrif as a targeted therapy for these additional non-resistant EGFR mutations significantly alters the treatment strategy for this population.”

To determine if a patient is eligible for Gilotrif, physicians must conduct a test for genetic mutations – also known as biomarker testing – to determine the type of EGFR mutation present.

“This approval is more welcome news for our lung cancer community,” said Laurie Fenton Ambrose, president and CEO of Lung Cancer Alliance. “These types of advances are helping expand access to treatment options for patients who might benefit from targeted therapies to fight their specific type of lung cancer.”

About NSCLC

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer. In some people, genetic mutations lead to the constant activation of the epidermal growth factor receptor (EGFR) protein, which is associated with uncontrolled cell division and the development and progression of NSCLC. Most cases of EGFR mutation-positive NSCLC are attributed to the two most common EGFR mutations (exon 19 deletions or L858R). Approximately 10 percent of NSCLC patients with EGFR mutations have rare or uncommon mutations, and have had limited treatment options available to them.

About Boehringer Ingelheim in Oncology

Boehringer Ingelheim’s oncology research is driven by a passion to advance clinical practice and a determination to improve the lives of patients who are battling cancer. Through our own scientific innovation and partnerships, we are focused on discovering and providing novel best-in-class, breakthrough cancer medications that fit the needs of patients, caregivers and healthcare professionals. We have a clear strategy to become a leader in the field of lung cancer. Boehringer Ingelheim has successfully launched two products globally for NSCLC that have been widely adopted and established as valuable additions to current clinical practice. Continuous insights and learnings from research and development are key parts of innovation and our way forward to advance clinical practice in lung cancer and other cancer types.

About Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and about 50,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.

In 2016, Boehringer Ingelheim achieved net sales of about $17.6 billion (15.9 billion euros). R&D expenditure corresponds to 19.6 percent of its net sales.

Source: Boehringer Ingelheim

Posted: January 2018

Related Articles:

Gilotrif (afatinib) FDA Approval History

Tagged with:

About author

Related Articles