XOSPATA is FDA Approved for Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation

CARY, N.C., December 7, 2018Biologics by McKesson, an independent specialty pharmacy for oncology and other complex therapeutic areas, announced that it has been selected by Astellas Pharma US, Inc. to be in the limited distribution network for XOSPATA® (gilteritinib).

XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory Acute Myeloid Leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test. XOSPATA was approved by the U.S. Food and Drug Administration (FDA) on November 28, 2018, based on an interim analysis of data from the ongoing phase III ADMIRAL trial. In May 2018, the FDA accepted, with Priority Review, the company’s New Drug Application (NDA) for gilteritinib. Previously, gilteritinib was granted both Orphan Drug designation and Fast Track designation by the FDA. 

Acute Myeloid Leukemia (AML) is a cancer that impacts the blood and bone marrow, and its incidence increases with age. The American Cancer Society estimates that in 2018, approximately 19,000 new patients will be diagnosed with AML in the U.S. XOSPATA is the first and only FLT3-targeting agent approved by the FDA for the treatment of adult patients with relapsed or refractory FLT3 mutation-positive (FLT3mut+) AML.

“Patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia have had limited treatment options,” said Brandon Tom, PharmD, vice president, Commercial Services, Biologics by McKesson. “We are pleased to be able to offer this much needed new drug to this patient population, who accounts for approximately 30 percent of all AML patients.”

Biologics by McKesson is committed to and recognized for its high level of customer service as well as its innovative, high-touch and multidisciplinary patient-centric approach. Each team includes a pharmacist with in-depth knowledge of oncology therapies, an experienced oncology nurse and a financial counselor who is familiar with various financial assistance programs and organizations that help cancer patients. This highly-skilled care team works together to develop individualized care plans that address each patient’s unique clinical, financial and emotional needs and streamlines communication back to the treating provider, enabling high-quality care and differentiated outcomes. In addition, the Biologics by McKesson team works closely with payers to ensure patients can access the specialty medications they need.

Physicians may submit prescriptions to Biologics by McKesson via phone (800.850.4306), fax (800.823.4506) or eScribe. For electronic prescribing systems, physicians may search for Biologics within their EMR system.


About Biologics by McKesson

Biologics by McKesson is an independent specialty pharmacy with over 24 years of experience connecting patients to life-changing medications in oncology and other complex therapeutic areas. Built on the foundation of deep clinical expertise and a high-touch approach to patient care, Biologics by McKesson delivers seamless access and personalized engagement, so patients get the most out of the care they receive. As part of McKesson Life Sciences, a business within McKesson Corporation, Biologics by McKesson harnesses unparalleled reach and connectivity across the healthcare system to connect the dots between payers, providers and biopharma, so together, they can deliver better care and outcomes for every patient.

Claire Crye, Public Relations
t 281.825.9927 claire.crye@mckesson.com