Is afatinib FDA approved?
Is afatinib FDA approved?
FDA broadens afatinib indication to previously untreated, metastatic NSCLC with other non-resistant EGFR mutations. On January 12, 2018, the Food and Drug Administration granted approval to afatinib (Gilotrif, Boehringer Ingelheim Pharmaceutical, Inc.)
Who owns afatinib?
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Who makes GILOTRIF?
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.
What is afatinib target?
Like lapatinib and neratinib, afatinib is a protein kinase inhibitor that also irreversibly inhibits human epidermal growth factor receptor 2 (Her2) and epidermal growth factor receptor (EGFR) kinases.
What is afatinib used for?
Afatinib is used to treat certain types of non-small cell lung cancer that has spread to nearby tissues or to other parts of the body. Afatinib is in a class of medications called kinase inhibitors.
Is afatinib better than erlotinib?
This study shows that afatinib has clinical efficacy as second-line treatment for patients with squamous cell carcinoma of the lung. Afatinib reduced the risk of death compared with erlotinib and also improved progression-free survival, health-related quality-of-life outcomes, and symptom control.
What is the best time to take afatinib?
You take afatinib once a day on an empty stomach. You take them at least one hour before eating or 3 hours after eating. You usually carry on taking it for as long as it is still working, unless the side effects get too bad.
What inhibits EGFR?
Two predominant classes of EGFR inhibitors have been developed including monoclonal antibodies (mAbs) that target the extracellular domain of EGFR, such as cetuximab (Erbitux), and small molecule tyrosine kinase inhibitors (TKIs) that target the receptor catalytic domain of EGFR, such as gefitinib (Iressa) and …
Who are the patients in Lux-Lung 7?
LUX-Lung 7 is the first global, head-to-head trial comparing second- and first-generation EGFR-directed therapies (afatinib and gefitinib respectively) for patients with EGFR mutation-positive NSCLC who received no prior treatment. The Phase IIb trial included 319 patients with advanced stage NSCLC harboring common EGFR mutations (del19 or L858R).
What was the outcome of the Lux-Lung 7 trial?
Updated results also confirmed the primary analysis that showed the global Phase IIb LUX-Lung 7 trial met two of its three co-primary endpoints of progression-free survival (PFS) by independent review and time to treatment failure (a measure of time between start and discontinuation of treatment for any reason).
Which is better Lux-Lung 7 or Iressa?
About the LUX-Lung 7 trial. LUX-Lung 7 is the first global, head-to-head trial comparing second- and first-generation EGFR-directed therapies (afatinib and gefitinib respectively) for patients with EGFR mutation-positive NSCLC who received no prior treatment.
Which is better afatinib or gefitinib for lung cancer?
This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in first-line treatment setting with patients who are having epidermal growth factor receptor mutation positive advanced adenocarcinoma of the lung. afatinib once daily.