Loxo Oncology Announces Receipt of Breakthrough Therapy Designation from U.S. Food and Drug Administration for LOXO-292
September 05 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 metastatic RET-fusion-positive
non-small cell lung cancer who require systemic therapy and have
progressed following platinum-based chemotherapy and an anti-PD-1
or anti-PD-L1 therapy; and for
- the treatment of patients with RET-mutant medullary thyroid
cancer who require systemic therapy, have progressed following
prior treatment and have no acceptable alternative treatment
options.
“We look forward to working with FDA to streamline the
development of LOXO-292 in the two patient populations that have
comprised the bulk of our initial clinical trial enrollment,” said
Josh Bilenker, M.D., chief executive officer at Loxo Oncology.
“Given the many available therapies for non-small cell lung cancer
and medullary thyroid cancer, we are pleased that LOXO-292 has
shown encouraging data in refractory patients, and hope to
demonstrate the full potential of this treatment in additional
populations over time.”
The LOXO-292 Breakthrough Therapy Designation was based on data
from the ongoing global Phase 1/2 LIBRETTO-001 clinical trial. In
2019, the company plans to provide an update on the overall
long-term LOXO-292 clinical development plan, based on feedback
from global regulators.
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-292 LOXO-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
the 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 CohenDirector, Corporate
Communicationslcohen@loxooncology.com
Investors:Peter RahmerEndurance Advisors,
LLC415-515-9763prahmer@enduranceadvisors.com
Media:Dan Budwick1AB Media973-271-6085dan@1abmedia.com
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