GLG News by Radiation Oncologists

Varian's flat panel is not digital fluoroscopy for treatment planning, but for image guided radiotherapy for daily treatment delivery - a big difference.   This panel is for a state of the art treatment delivery techniquie    

How can the FDA approve something that fails to meet the primary endpoint of the trial?   Hence the approval letter            

While phase I and phase II data can show promising results, the proof in concept is whether a novel agent improves over standard of care medicine.   This is another example of a 'promising' drug that has not proven itself. 

These drugs already have a proven value.

Stock was up on preliminary FDA approval, however, the FDA has mandated that final approval would be dependent on ongoing trial.    This will certainly delay any growth for Dendreon/Provenge at this time.  

1.  Taxotere improves tumor control and survival in head and neck cancer patients when used during induction chemotherapy2.  Taxotere is well tolerated3.  Few, if any, competing FDA-approved drugs in head and neck cancer