XOSPATA® (gilteritinib) Available at Biologics by McKesson

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

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
 designation and Fast
 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+)

“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

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

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
, 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