Managed access is like compassionate care and for men that have tried all other available options. It is for those that have runout of treatments. It is a clinical trial through Novartis. Our oncologist requested the drug and once Jim had the PSMA scan, Novartis approved the use. The delay comes next as the oncologist has to fill out forms for the FDA and get its approval. The next step was approval from Fox Chase’s regulatory board. In all, that took about a month. One needs an oncologist that understands what must be done to get approval through managed access. I believe an oncologist can also request immediate access for the drug. I forget what that is called but we researched and read about it. It is for someone who can’t afford to wait.
Managed access for Lu 177: Managed... - Advanced Prostate...
Managed access for Lu 177
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Julson
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