U.S. FDA Approves Supplemental New Drug Application Adding Overall Survival Data for XOSPATA® (gilteritinib)

- Phase 3 ADMIRAL trial showed patients treated with XOSPATA demonstrated longer Overall Survival than those who received salvage chemotherapy[1] -

- XOSPATA is the only FDA-approved targeted treatment for adult patients with relapsed or refractory FLT3 mutation-positive Acute Myeloid Leukemia[1] -

TOKYO, Japan I May 30, 2019 I Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. "Astellas") today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the U.S. product labeling for XOSPATA® (gilteritinib) to include final analysis data from the ADMIRAL trial. The data demonstrated improvement in Overall Survival in those treated with gilteritinib monotherapy versus salvage chemotherapy in adult patients with relapsed (disease that has returned) or refractory (resistant to treatment) Acute Myeloid Leukemia (AML) with an FMS-like tyrosine kinase 3 (FLT3) mutation.

"The ADMIRAL trial's Overall Survival (OS) findings are encouraging for patients and families impacted by relapsed/refractory FLT3 mutation-positive AML," said Alexander Perl, M.D., Abramson Cancer Center, University of Pennsylvania. "The data underscore the importance of single-agent XOSPATA for this patient population that, until recently, had few remaining treatment options."

Results from the ADMIRAL trial show the median OS for patients who received XOSPATA was 9.3 months compared to 5.6 months for patients who received salvage chemotherapy (Hazard Ratio = 0.64 (95% CI 0.49, 0.83), P=0.0004). The other co-primary endpoints of Complete Remission (CR)/Complete Remission with Partial Hematologic Recovery (CRh) in the XOSPATA arm at the interim analysis was 21% (95% CI: 14.5, 28.8).1

The safety profile of XOSPATA is based on 319 patients with relapsed or refractory AML in three clinical trials (NCT02421939, NCT02014558, and NCT02181660). Fatal adverse reactions occurred in 2% of patients receiving XOSPATA. These included cardiac arrest (1%) and one case each of differentiation syndrome and pancreatitis. The most frequent (≥5%) nonhematological serious adverse reactions reported in patients were fever (13%), dyspnea (9%), renal impairment (8%), transaminase increased (6%) and noninfectious diarrhea (5%). The most frequent (≥5%) grade ≥3 nonhematological adverse reactions reported in patients were transaminase increased (21%), dyspnea (12%), hypotension (7%), mucositis (7%), myalgia/arthralgia (7%), and fatigue/malaise (6%).

Please see Important Safety Information including BOXED WARNING at the end of this press release.

"Delivering innovation and value to address the unmet medical needs of patients is at the core of everything we do," said Bernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas. "The FDA's approval of the sNDA based on Overall Survival data further highlights the strong potential XOSPATA has to help patients suffering from FLT3 mutation-positive AML, a life-threatening disease."

The initial approval of XOSPATA in November 2018 by the FDA was based on an interim analysis of the following endpoints in the ADMIRAL clinical trial: the rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh); the duration of CR/CRh (DOR); and the rate of conversion from transfusion dependence to transfusion independence. 

The FDA reviewed the sNDA for XOSPATA under the Oncology Center of Excellence Real-Time Oncology Review pilot program, which aims to explore a more efficient review process by allowing the FDA to evaluate clinical data as soon as trial results become available.

XOSPATA was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and commercialize XOSPATA.

XOSPATA was approved by the Japan Ministry of Health, Labor and Welfare (MHLW) for relapsed or refractory AML with FLT3 mutations and launched as XOSPATA® 40 mg Tablets in 2018.2 In February 2019, the European Medicines Agency accepted a marketing authorization application (MAA) for regulatory review. The MAA is for the oral once-daily therapy XOSPATA for the treatment of adult patients who have relapsed or refractory AML with a FLT3 mutation.3

Astellas is currently investigating gilteritinib in various FLT3 mutation-positive AML patient populations through several Phase 3 trials. Visit http://www.clinicaltrials.gov to learn more about ongoing gilteritinib clinical trials.

About the ADMIRAL Trial4
The Phase 3 ADMIRAL trial (NCT02421939) was an open-label, multicenter, randomized study of gilteritinib versus salvage chemotherapy in adult patients with FLT3 mutations who are refractory to, or have relapsed after, first-line AML therapy. The co-primary endpoints of the trial were Overall Survival and Complete Remission (CR)/Complete Remission with Partial Hematologic Recovery (CRh). The study enrolled 371 patients with relapsed or refractory AML and positive for FLT3 mutations present in bone marrow or whole blood. Subjects were randomized in a 2:1 ratio to receive gilteritinib (120 mg) or salvage chemotherapy.

About XOSPATA® (gilteritinib)
XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory Acute Myeloid Leukemia (AML) with an FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.1 

About Astellas
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information, please visit our website at www.astellas.com/en.

1 XOSPATA [package insert]. Northbrook, IL: Astellas Pharma US, Inc.

2 Astellas Pharma Inc. Astellas Announces Approval in Japan for XOSPATA® 40 mg Tablets for the Treatment of FLT3mut+ Relapsed or Refractory AML (09-21-2018). https://www.astellas.com/en/news/14271. Accessed 05-30-2019.

3 Astellas Pharma Inc. Astellas Announces Acceptance of XOSPATATM (gilteritinib) for Regulatory Review by the European Medicines Agency (02-28-2019). https://www.astellas.com/us/news/14631.  Accessed 05-30-2019.

4 ClinicalTrials.gov. A study of ASP2215 versus salvage chemotherapy in patients with relapsed refractory acute myeloid leukemia (AML) with FMS-like tyrosine kinase (FLT3) mutation (02-21-2019.) https://clinicaltrials.gov/ct2/show/NCT02421939. Accessed 05-30-2019.

SOURCE: Astellas Pharma

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