DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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AFATINIB
FRIDAY July 12, 2013 — A new drug to treat advanced lung cancer has been approved by the U.S. Food and Drug Administration.
Gilotrif (afatinib) is approved to treat patients with a specific subtype of of non-small cell lung cancer (NSCLC). About 85 percent of lung cancers are NSCLC, making it the most common type of lung cancer.
Gilotrif is approved to treat tumors that carry key deletions on the epidermal growth factor receptor (EGFR) gene, long a target for lung cancer therapeutics. Mutations in the EGFR gene are thought to occur in about 10 percent of non-small cell lung cancers, and most of those mutations are targeted by Gilotrif, the FDA said.http://www.drugs.com/news/fda-approves-new-gilotrif-advanced-lung-cancer-45917.html
Afatinib (INN; planned trade name Tomtovok, previously Tovok) is a candidate drug against non-small cell lung carcinoma (NSCLC), developed by Boehringer Ingelheim. As of July 2012, it is undergoing Phase III clinical trials for this indication and breast cancer, as well as Phase II trials for prostateand head and neck cancer,and a Phase I glioma trial , Afatinib is not a first-line treatment; it is only used after other therapies have failed.
In October 2010 a Phase III trial in NSCLC patients called Lux-Lung 5 began with this drug Fall 2010 interim results suggested the drug extended progression-free survival threefold compared to placebo, but did not extend overall survival.In May 2012, the Phase IIb/III trial Lux-Lung 1 came to the same conclusion.
Phase II results for breast cancer that over-expresses the protein human epidermal growth factor receptor 2 (Her2-positive breast cancer) were described as promising by the authors, with 19 of 41 patients achieving benefit from afatinib. Double-blind Phase III trials are under way to confirm or refute this finding. Her2-negative breast cancers showed limited or no response to the drug
New Drug Approvals 
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