FDA approves gilteritinib for refractory AML

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

FDA approved the addition of overall survival data in labeling for gilteritinib (Xospata), which is indicated for adult patients who have relapsed or refractory acute myeloid leukemia with a FLT3 mutation as detected by an FDA-approved test.

The drug is sponsored by Astellas Pharma US, Inc.

Approval was based on the ADMIRAL trial (NCT02421939), which included 371 adult patients with relapsed or refractory AML having a FLT3 ITD, D835, or I836 mutation identified by the LeukoStrat CDx FLT3 Mutation Assay.

Patients were randomized (2:1) to receive Xospata 120 mg once daily (n=247) over continuous 28-day cycles or prespecified salvage chemotherapy (n=124). Salvage chemotherapy included either intensive cytotoxic chemotherapy or a low-intensity regimen.

For the analysis, OS was measured from the randomization date until death by any cause. The median OS was 9.3 months for patients receiving gilteritinib and 5.6 months for those on the chemotherapy arm (HR 0.64; 95% CI: 0.49,0.83; 1 sided p-value=0.0004).

The results were consistent in the intensive chemotherapy stratum (HR 0.66; 95% CI: 0.47-0.93) and the low-intensity regimen stratum (HR 0.56; 95% CI: 0.38-0.84).

The recommended gilteritinib dose is 120 mg orally once daily.

YOU MAY BE INTERESTED IN

The University of California, San Francisco and global oncology communities mourn the death of Felix Y. Feng, MD, a radiation oncologist and a leading figure in genitourinary cancer research. A professor of radiation oncology, urology and medicine, and vice chair of translational research at the UCSF Helen Diller Family Comprehensive Cancer Center, Feng died from cancer on Dec.10, 2024. He was 48.
The late Felix Feng, MD (center) with researchers Jonathan Chou, MD, PhD (left) and Lisa Chesner, PhD (right), in 2019.Photo by Noah BergerFelix Y. Feng, a genitourinary cancer research leader, died on Dec. 10, 2024. He was 48.This article is republished with permission by NRG Oncology.Dr. Feng was the former NRG Oncology Genitourinary Cancer Committee chair and an RTOG Foundation member. After years of dedicated and enthusiastic commitment to the NRG and previously the RTOG Genitourinary Cancer Committee, chairing or co-chairing 13 research protocols for NRG and RTOG, Dr. Feng was appointed committee chair in March 2018, following in the footsteps of Dr. Howard Sandler, his mentor. Dr. Feng was also a member of the RTOG Foundation Board of Directors.

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login