Loxo Oncology Announces FDA Orphan Drug Designation Granted to Larotrectinib for the Treatment of Solid Tumors with NTRK-Fusi...
May 12 2017 - 6:45AM
Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company
innovating the development of highly selective medicines for
patients with genetically defined cancers, today announced that the
U.S. Food and Drug Administration (FDA) has granted orphan drug
designation to larotrectinib for the “treatment of solid tumors
with NTRK-fusion proteins.” NTRK fusions are genetic abnormalities
that occur rarely in various adult and pediatric solid tumors.
The FDA’s Office of Orphan Drug Products grants orphan drug
designation to support the development of medicines for underserved
patient populations, or rare disorders, that affect fewer than
200,000 people in the United States. Orphan drug designation
provides to Loxo Oncology certain benefits, including market
exclusivity upon regulatory approval if received, exemption of FDA
application fees and tax credits for qualified clinical trials.
About Larotrectinib (LOXO-101)
Larotrectinib
(LOXO-101) is a potent, oral and selective investigational new drug
in clinical development for the treatment of patients with cancers
that harbor abnormalities involving the tropomyosin receptor
kinases (TRKs). Growing research suggests that the NTRK genes,
which encode for TRKs, can become abnormally fused to other genes,
resulting in growth signals that can lead to cancer in many sites
of the body. In an ongoing Phase 1 clinical trial, larotrectinib
has demonstrated encouraging preliminary efficacy. Larotrectinib is
also being evaluated in the NAVIGATE global Phase 2 multi-center
basket trial in patients with solid tumors that harbor TRK gene
fusions, and the SCOUT Phase 1/2 trial in pediatric patients,
including patients with advanced cancer, TRK gene fusions and
infantile fibrosarcoma. Larotrectinib has been granted Breakthrough
Therapy Designation, Rare Pediatric Disease Designation, and Orphan
Drug Designation by the U.S. FDA. For additional information
about the larotrectinib clinical trials, please refer
to www.clinicaltrials.gov. Interested patients and physicians
can contact the Loxo Oncology Physician and Patient Clinical Trial
Hotline at 1-855-NTRK-123 or
visit www.loxooncologytrials.com.
About Loxo OncologyLoxo Oncology is a
biopharmaceutical company innovating the development of highly
selective medicines for patients with genetically defined cancers.
Our pipeline focuses on cancers that are uniquely dependent on
single gene abnormalities, such that a single drug has the
potential to treat the cancer with dramatic effect. We believe that
the most selective, purpose-built medicines have the highest
probability of maximally inhibiting the intended target, thereby
delivering best-in-class disease control and safety. Our management
team seeks out experienced industry partners, world-class
scientific advisors and innovative clinical-regulatory approaches
to deliver new cancer therapies to patients as quickly and
efficiently as possible. For more information, please visit the
company's website at www.loxooncology.com.
Forward Looking StatementsThis press release
contains "forward-looking" statements within the meaning of the
safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995. Forward-looking statements can be identified by
words such as: "anticipate," "intend," "plan," "goal," "seek,"
"believe," "project," "estimate," "expect," "strategy," "future,"
"likely," "may," "should," "will" and similar references to future
periods. These statements are subject to numerous risks and
uncertainties that could cause actual results to differ materially
from what we expect. Examples of forward-looking statements
include, among others, the reporting, timing and success of our
clinical trials. Further information on potential risk factors that
could affect our business and its financial results are detailed in
our most recent Quarterly Report on Form 10-Q, and other reports as
filed from time to time with the Securities and Exchange
Commission. We undertake no obligation to publicly update any
forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of new information,
future developments or otherwise.
Contacts for Loxo Oncology, Inc.
Company:
Jacob S. Van Naarden
Chief Business
Officer
jake@loxooncology.com
Investors:
Peter Rahmer
The Trout Group,
LLC
646-378-2973
prahmer@troutgroup.com
Media:
Dan Budwick
1AB Media973-271-6085
dan@1abmedia.com
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