FDA OKs Addition of Overall Survival Data in Gilteritinib Labeling for AML

Officials with the FDA approved the addition of overall survival (OS) data in labeling for gilteritinib (Xospata, Astellas Pharma), which is indicated for adults with relapsed/refractory acute myeloid leukemia (AML) with an FMS-like tyrosine kinase 3 (FLT3) mutation, according to a press release.
The approval was based on final analysis data from the ADMIRAL clinical trial, which included 371 adults with relapsed/refractory AML having a FLT3, ITD, D835, or I836 mutation as detected by an FDA-approved test. The data showed improvement in OS in patients treated with 120 mg gilteritinib monotherapy compared with salvage chemotherapy. Salvage chemotherapy included either intensive cytotoxic chemotherapy or a low-intensity regimen.
For the study, patients were randomized to receive gilteritinib 120 mg once daily over continuous 28-day cycles or prespecified salvage chemotherapy. Results from the trial demonstrated that the median OS for patients who received gilteritinib was 9.3 months compared with 5.6 months for those who received salvage chemotherapy (Hazard Ratio = 0.64 (95% CI 0.49, 0.83, P=0.0004). According to the data, the results were consistent in the intensive chemotherapy stratum (HR 0.66; 95% CI: 0.47-0.93) and the low-intensity regimen (HR 0.56; 95% CI: 0.38-0.84).
The FDA’s initial approval of gilteritinib in November 2018 was based on an interim analysis of 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 most frequent adverse effects that occurred in at least 20% of patients receiving gilteritinib were increased transaminase, myalgia/arthralgia, fatigue/malaise, fever, mucositis, edema, rash, noninfectious diarrhea, dyspnea, nausea, cough, constipation, eye disorders, headache, dizziness, hypotension, vomiting, and renal impairment.
“The ADMIRAL trial’s overall survival findings are encouraging for patients and families impacted by relapsed/refractory FLT3 mutation-positive AML,” Alexander Perl, MD, Abramson Cancer Center, University of Pennsylvania, said in a statement. “The data underscore the importance of single-agent Xospata for this patient population that, until recently, had few remaining treatment options.”

At the 2019 Hematology/Oncology Pharmacy Association Annual Conference, Bernard Marini, PharmD, BCOP, an inpatient hematology specialist at the University of Michigan, sat down with Specialty Pharmacy Times® to discuss the use of different therapies for patients with AML. In this clip, Dr Marini gives an overview of selecting the most effective, safest, and most cost-effective treatment for patients. 

US FDA Approves Supplemental New Drug Application Adding Overall Survival Data for XOSPATA (gilteritinib) [news release]. Astellas Pharma. https://newsroom.astellas.us/2019-05-30-U-S-FDA-Approves-Supplemental-New-Drug-Application-Adding-Overall-Survival-Data-for-XOSPATA-R-gilteritinib. Accessed May 30, 2019.

Stay up to date on the latest news in specialty pharmacy by getting Specialty Pharmacy Times in your mailbox or inbox for free!

Click here to sign up for free for the bi-monthly Specialty Pharmacy Times print journal delivered to your address.

Click here to sign up for our email newsletters delivered every Monday, Wednesday, and Friday, in addition to breaking news alerts.

Click here to follow us on Facebook. 

Click here to follow us on Twitter. 

Click here to join our LinkedIn group. 

Related Articles

Moderate physical activity may improve progression-free survival and reduce treatment-related adverse effects in patients undergoing chemotherapy for advanced colorectal cancer.
A recent study demonstrates the clinical benefit from the use of direct-acting antivirals for hepatitis C virus in patients with a history of liver cancer.
Cancers of the lung, breast, prostate, and colon are most common in adults aged 85 years and older.
Company Profile >
Industry Guide >
Market News >
Peer Exchange >
Conferences >
Subscribe >
Specialty Times Resources
About Us
Contact Us
Terms & Conditions
MJH Associates >
Pharmacy Times
American Journal of Managed Care
MD Magazine
Targeted Oncology
Physicians' Education Resource
Pharmacy & Healthcare Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747

Copyright Specialty Pharmacy Times 2006-2019
Pharmacy & Healthcare Communications, LLC. All Rights Reserved.