Zytiga therapy fits most naturally into the treatment strategy for prostate cancer before chemotherapy is used. It is far safer than chemotherapy and so should be used first. Zytiga is a form of hormone therapy that is capable of total androgen ablation and so it makes sense to use Zytiga after other forms of androgen deprivation therapy (ADT) have failed but before chemotherapy is needed. This is the subject of the current sNDA application for FDA approval of Zytiga before chemotherapy. The EMA committee on medicine use in humans has already recommended Zytiga after ADT has failed, i.e. before chemotherapy, and this should lead to EMA approval in Europe early next year.
Presently the FDA approval is limited to use of Zytiga after chemotherapy has failed. This has led to the use of chemotherapy to qualify for Zytiga treatment which is a consequence of the current legislation. Zytiga can presently be used off-label at the Doctors discretion for the treatment of prostate cancer before chemotherapy but this is not generally covered by insurance companies until it is FDA approved in this category.
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