Loxo Oncology Announces Receipt of Breakthrough Therapy Designation from U.S. Food and Drug Administration for LOXO-292 for t...
October 15 2018 - 6:45AM
Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company
developing highly selective medicines for patients with genomically
defined cancers, today announced that the U.S. Food and Drug
Administration (FDA) has granted Breakthrough Therapy Designation
to LOXO-292, a selective RET inhibitor, for the treatment of
patients with advanced RET fusion-positive thyroid cancer who
require systemic therapy, have progressed following prior treatment
and have no acceptable alternative treatment options. This
designation supplements the two LOXO-292 Breakthrough Therapy
Designations granted in September 2018. The Breakthrough Therapy
Designation announced today was also based on data from the ongoing
global Phase 1/2 LIBRETTO-001 clinical trial.
The FDA's Breakthrough Therapy Designation is intended to
expedite the development and review of a drug candidate that is
planned for use to treat a serious or life-threatening disease or
condition when preliminary clinical evidence indicates that the
drug may demonstrate substantial improvement over existing
therapies on one or more clinically significant endpoints.
About LOXO-292LOXO-292 is an oral and selective
investigational new drug in clinical development for the treatment
of patients with cancers that harbor abnormalities in the
rearranged during transfection (RET) kinase. RET fusions and
mutations occur across multiple tumor types with varying frequency.
LOXO-292 was designed to inhibit native RET signaling as well as
anticipated acquired resistance mechanisms that could otherwise
limit the activity of this therapeutic approach. LOXO-292 has been
granted Breakthrough Therapy Designation by the U.S. FDA.
LOXO-292 is currently being studied in the global LIBRETTO-001
Phase 1/2 trial. For additional information about the LOXO-292
clinical trial, please refer to www.clinicaltrials.gov. Interested
patients and physicians can contact the Loxo Oncology Physician and
Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email
clinicaltrials@loxooncology.com.
About RET-Altered CancersGenomic alterations in
RET kinase, which include fusions and activating point mutations,
lead to overactive RET signaling and uncontrolled cell growth. RET
fusions have been identified in approximately 2% of non-small cell
lung cancer, 10-20% of papillary and other thyroid cancers, and a
subset of other cancers. Activating RET point mutations account for
approximately 60% of medullary thyroid cancer (MTC). Both RET
fusion cancers and RET-mutant MTC are primarily dependent on this
single activated kinase for their proliferation and survival. This
dependency, often referred to as “oncogene addiction,” renders such
tumors highly susceptible to small molecule inhibitors targeting
RET.
About Loxo Oncology Loxo Oncology is
a biopharmaceutical company developing highly selective medicines
for patients with genomically 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, with the intention of
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 Statements This 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 the LIBRETTO-001 trial and LOXO-292, and the timing or success
of regulatory approvals. Further information on potential risk
factors that could affect our business and its financial results
are detailed in our most recent Annual Report on Form 10-K, 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: Lauren Cohen Director, Corporate Communications
lcohen@loxooncology.com
Investors: Peter Rahmer Endurance Advisors, LLC 415-515-9763
prahmer@enduranceadvisors.com
Media: Dan Budwick 1AB Media 973-271-6085 dan@1abmedia.com
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