Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company
developing highly selective medicines for patients with genomically
defined cancers, today announced that its collaboration partner,
Bayer, has submitted a marketing authorization application (MAA)
for larotrectinib to the European Medicines Agency (EMA).
Larotrectinib is being investigated to potentially treat adult and
pediatric patients with locally advanced or metastatic solid tumors
with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
“Larotrectinib has demonstrated exciting clinical responses in
patients with TRK fusion cancer across various tumor types in both
children and adults,” said Ulrik Lassen, M.D., Ph.D., Department of
Oncology, Rigshospitalet, Copenhagen. “The regulatory submission of
larotrectinib in Europe moves us closer to being able to provide a
targeted treatment option to these patients for which there is
currently no approved therapy.”
Loxo Oncology and Bayer are engaged in a collaboration for the
development and commercialization of larotrectinib. In May 2018,
larotrectinib was granted Priority Review by the U.S. Food and Drug
Administration (FDA) for the treatment of adult and pediatric
patients with locally advanced or metastatic solid tumors harboring
an NTRK gene fusion. The FDA has set a target action date of
November 26, 2018, under the Prescription Drug User Fee Act
(PDUFA).
About Larotrectinib Larotrectinib is an oral
and selective investigational tropomyosin receptor kinase (TRK)
inhibitor in clinical development for the treatment of patients
with cancers that harbor a neurotrophic tyrosine receptor kinase
(NTRK) gene fusion. 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 clinical trials,
larotrectinib demonstrated anti-tumor activity in patients with
tumors harboring NTRK gene fusions, regardless of patient age or
tumor type. In an analysis of 55 RECIST-evaluable adult and
pediatric patients with NTRK gene fusions, using a July 17, 2017
data cutoff, larotrectinib demonstrated a 75 percent
centrally-assessed confirmed overall response rate (ORR) and an 80
percent investigator-assessed confirmed ORR, across many different
types of solid tumors. The majority (93 percent) of all adverse
events were grade 1 or 2.
Larotrectinib has been granted Priority Review, Breakthrough
Therapy Designation, Rare Pediatric Disease Designation and Orphan
Drug Designation by the U.S. FDA.
In November 2017, Loxo Oncology and Bayer entered
into an exclusive global collaboration for the development and
commercialization of larotrectinib and LOXO-195, a next-generation
TRK inhibitor. Bayer and Loxo Oncology are jointly developing
the two products with Loxo Oncology leading the ongoing
clinical studies as well as regulatory filings in the U.S., and
Bayer leading ex-U.S. regulatory activities and worldwide
commercial activities. In the U.S., Loxo Oncology and
Bayer will co-promote the products.
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/trk-trials.
About TRK Fusion Cancer TRK fusion cancer
occurs when a neurotrophic tyrosine receptor kinase
(NTRK) gene fuses with another unrelated gene, producing an
altered tropomyosin receptor kinase (TRK) protein. The altered
protein, or TRK fusion protein, is constantly active, triggering a
permanent signal cascade. These proteins become the primary driver
of the spread and growth of tumors in patients with TRK fusion
cancer. TRK fusion cancer is not limited to certain types of cells
or tissues and can occur in any part of the body. NTRK gene fusions
occur in various adult and pediatric solid tumors with varying
prevalence, including appendiceal cancer, breast cancer,
cholangiocarcinoma, colorectal cancer, GIST, infantile
fibrosarcoma, lung cancer, mammary analogue secretory carcinoma of
the salivary gland, melanoma, pancreatic cancer, thyroid cancer,
and various sarcomas.
Only sensitive and specific tests can reliably detect TRK fusion
cancer. Next-generation sequencing (NGS) can provide a
comprehensive view of genomic alterations across a large number of
genes. Fluorescence in situ hybridization (FISH) can also be used
to test for TRK fusion cancer, and immunohistochemistry (IHC) can
be used to detect the presence of TRK protein.
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 timing and success of our clinical
trials or regulatory approvals related to larotrectinib, the
success of our collaboration with Bayer and our commercial
activities. 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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