Targeted failures of the week. Post No 82 and 83. Tykerb and Tivozanib

GlaxoSmithKline  recently announced disappointing data from a global phase III study evaluating the use of Tykerb in patients suffering from human epidermal growth factor receptor 2 (HER2) positive advanced gastric cancer.

 The randomized, multi-center, double-blinded, phase III study compared the efficacy and tolerability of Tykerb as an adjunct to Sanofi’s Eloxatin (oxaliplatin) and Roche Holding’s Xeloda (capecitabine) versus Eloxatin, Xeloda and placebo in treatment naïve HER2-positive advanced gastric cancer patients.

Results from the study revealed that the treatment with Tykerb did not cause significant improvement in overall survival (:OS), thus failing to meet the primary endpoint of the study. The median OS was 12.2 months in the Tykerb plus Eloxatin and Xeloda arm compared with 10.5 months for the Eloxatin, Xeloda and placebo arm.

Aveo Oncology said the U.S. Food and Drug Administration denied approval for its experimental kidney cancer drug citing inconsistent trial results and asked for an additional study.

In a complete response letter to the company, the health regulator said inconsistent survival data from the drug tivozanib's trials made the results "uninterpretable and inconclusive."

What's wrong with the World? Why Big Pharma produces targeted drugs which are wrong-targeted?