Astellas Pharma ((ALPMF)), Astellas Pharma ((ALPMY)) announced an update on their ongoing clinical study.
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Astellas Pharma is conducting a Phase 3 study titled A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation. The study aims to assess the clinical benefit of ASP2215, also known as Gilteritinib, in improving overall survival compared to salvage chemotherapy in patients with relapsed or refractory AML with FLT3 mutation. This study is significant as it targets a specific mutation in AML, potentially offering a more effective treatment option.
The intervention being tested is Gilteritinib, an oral drug administered daily in 28-day cycles, intended to improve survival rates in AML patients with the FLT3 mutation. The comparator is a range of salvage chemotherapy regimens.
The study design is interventional with a randomized allocation and a parallel intervention model. It is open-label, meaning no masking is involved, and its primary purpose is treatment.
The study began on October 25, 2017, with primary completion expected by November 6, 2024, and an estimated overall completion by July 30, 2025. These dates are crucial for tracking the progress and availability of results, which can influence treatment protocols and market dynamics.
This update could positively impact Astellas Pharma’s stock performance by highlighting the potential of Gilteritinib as a viable treatment option, potentially increasing investor confidence. Competitors in the AML treatment space may need to reassess their strategies in light of these developments.
The study is ongoing, with further details available on the ClinicalTrials portal.