Tinib in the treatment of non small lung cell cancer after failure of docetaxel r platinum-based chemotherapy [10,22,98]. The dependence of the efficacy of gefitinib on the mutation status was detected by in vivo and in vitro studies [10] after the start of phase III trials. Consequently, the failure of the first phase III trials (INTACT I [79] and II [80]) was due to a comparatively low rate of patients with EGFR mutations. In the ISEL trial [81] also no increase of overall survival time was detected, but a Methyl 3-amino-2,4-dichloro-5-fluorobenzoate substudy revealed that neversmokers had an increased survival time (8.5 vs 5.5 months). This effect was even greater in patients of Asian origin (9.5 vs 5.5 months).GefitinibAsian? populations have much higher rates of EGFR activating mutations. In response, the FDA revoked the accelerated approval of 2003 in 2005, and limited the indication to patients who were already on the drug and had benefited from it. In the INTEREST trial [8] the impact of activating EGFR mutations was clinically shown by a significantly higher response rate (42.1 vs 21.1 ). Accordingly, the IPASS study [9] on Asian patients demonstrated a higher response rate for gefitinib versus standard therapy and patients without the mutation did not respond to gefitinib. The EMEA approved gefitinib for the treatment of non small cell PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/8086425 lung cancer for patients carrying an activating EGFR mutation in 2009. In the evaluation of these studies the inclusion of the EGFR mutation status into the biomarker panel improved the overall translatability score from Boc-D-Lys-OH 2.54 to 4.25 (Table 2). This increase reflects higher individual scores for biomarker grading, biomarker development, strategy, clinical trials and personalized medicine items. The biomarker score alone would predict a high translatability also for the use of tumor growth as this is a widely used biomarker. Only the translatability score considers the importance of the mutation. This case clearly shows that the use of both scoring systems is important to more accurately predict success of the particular project. As already mentioned, gefitinib is an example of a drug in which personalized medicine aspects play a pivotal role for the responder rates. Instead of being a blockbuster with an indication for all lung cancer patients, gefitinib is only effective in 10-15 of the patients in Western countries. The company decided to push the compound before personalized medicine issues had been solved which were likely to exist. Therefore, the blockbuster-type approach was doomed to fail. The case of gefitinib is a good example for the trend to use more genetic biomarkers to aid personalization instead PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/17591728 of the development of block buster drugs in the field of oncology (and elsewhere). Additionally, the development of companion diagnostics is an important field of drug development, underlining the importance of biomarkers again, especially in oncology. Therefore the item for personalized medicine in this field is of great importance and 4-triazole-3 may eventually be weighted higher in oncology.VilazodoneVilazodone? (5-(4-[4-(5-cyano-3-indolyl)-butyl]-1-piperazinyl)-benzofuran-2carboxamide hydrochloride) was approved by the FDA in January 2011 for the treatment of major depressive disorder and is marketed as Viibryd ?by Clinical Data Inc. Despite the availability of approved drugs for the treatment of major depressive disorder, many patients do not adequately respond toWendler and Wehling Journal of Translational Medicine 2012, 10:39 http://www.tr.
