TOKYO (dpa-AFX) - Japan-based Astellas Pharma Inc. (ALPMY) on Monday announced results from the Phase 3 ADMIRAL clinical trial comparing Xospata (gilteritinib) to salvage chemotherapy in adult patients with relapsed or refractory (resistant to treatment) Acute Myeloid Leukemia or AML with a FLT3 mutation.
According to the company, the results showed that patients treated with Xospata had significantly longer Overall Survival or OS than those who received standard salvage chemotherapy.
The data were shared today by Alexander Perl, Abramson Cancer Center, University of Pennsylvania, in a press conference at the American Association for Cancer Research or AACR Annual Meeting.
The data will also be presented during the AACR Clinical Trials Plenary Session (CT184), which takes place April 2, 2019, at the Georgia World Congress Center.
Astellas Pharma noted that results from the ADMIRAL trial showed the median OS for patients who received Xospata was 9.3 months, compared to 5.6 months for patients who received salvage chemotherapy. One-year survival rates were 37 percent for patients who received Xospata, compared to 17 percent for patients who received salvage chemotherapy.
'We are very encouraged by the findings of the ADMIRAL trial. Patients with relapsed/refractory FLT3 mutation-positive AML generally have a poor prognosis and short survival. Until just recently, they had few treatment options. These findings change the treatment paradigm for this patient population,' said Alexander Perl, an associate professor of Hematology-Oncology in Penn's Perelman School of Medicine.
Xospata was approved by the U.S. Food and Drug Administration or FDA in November 2018 for the treatment of adult patients who have relapsed or refractory AML with a FLT3 mutation as detected by an FDA-approved test.
Xospata was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and commercialize Xospata.
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