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With respect to the substantial similarity criteria, the applicant asserted that VANFLYTA is not substantially similar to other currently available technologies because VANFLYTA is the first drug to be expressly developed ( as a FLT3 inhibitor, not a multi-kinase inhibitor, and specifically optimized to inhibit the FLT3-ITD AML, thereby targeting the subpopulation of newly diagnosed patients with the worst prognosis (higher risk of relapse and worse overall survival)

No fractions, no guessing

Suppressor of cytokine signaling 1 negatively regulates Toll-like receptor signaling by mediating Mal degradation

This means compounding pharmacies cannot include it in customized medications

10.1016/j.repbio.2019.07.002 149 Redza-DutordoirM.Averill-BatesD

Several factors support the theoretical viability of oral BPC-157, though human outcomes remain unproven: Gastric Stability: BPC-157 was originally studied for gastric protection in animal models, meaning the compound was administered directly into the stomach in research settings