WHIPPANY, N.J., March 26, 2018 /PRNewswire/ -- Bayer today
announced that its collaboration partner Loxo Oncology, Inc.,
(NASDAQ: LOXO) has completed the rolling submission of a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA)
for larotrectinib for the treatment of adult and pediatric patients
with locally advanced or metastatic solid tumors harboring a
neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The
rolling submission was initiated in December
2017. NTRK gene fusions are genetic alterations present
across a wide range of tumors resulting in uncontrolled tropomyosin
receptor kinase (TRK) signaling and tumor growth.
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"This NDA submission in the U.S. marks an important milestone in
bringing us one step closer to providing larotrectinib as a
potential treatment option for patients with TRK fusion cancer,"
said Scott Fields, MD, Bayer's
senior vice president and head of Oncology Development at Bayer's
Pharmaceutical Division. "NTRK gene fusions, while rare, are
present in various pediatric and adult cancers. We are committed to
working with the FDA and the oncology community to bring
larotrectinib to patients as soon as possible."
Bayer and Loxo Oncology are jointly developing larotrectinib, an
investigational compound being studied globally for the treatment
of patients across a wide range of cancers that harbor a NTRK gene
fusion. Bayer plans to submit a Marketing Authorization Application
(MAA) in the European Union in 2018.
About Larotrectinib (LOXO-101)
Larotrectinib
(LOXO-101) is an investigational oral and selective drug in
clinical development for the treatment of patients across a wide
range of cancers that harbor a neurotrophic tyrosine receptor
kinase (NTRK) gene fusion. Growing research suggests that the NTRK
genes, which encode for tropomyosin receptor kinases (TRKs), can
become abnormally fused to other genes, resulting in growth signals
that can lead to cancer in many sites of the body.
Larotrectinib has been granted Breakthrough Therapy Designation,
Rare Pediatric Disease Designation and Orphan Drug Designation
(ODD) by the U.S. Food and Drug Administration. For additional
information about the larotrectinib clinical trials, please refer
to www.clinicaltrials.gov or
visit www.loxooncologytrials.com. Larotrectinib has not been
approved by the U.S. Food and Drug Administration, the European
Medicines Agency or any other health authority.
In November 2017, Bayer and Loxo
Oncology entered into an exclusive global collaboration for the
development and commercialization of larotrectinib and LOXO-195, a
next-generation TRK inhibitor in clinical development. Bayer and
Loxo Oncology will jointly develop the two products with Loxo
Oncology leading the ongoing clinical studies as well as the filing
in the U.S., and Bayer leading ex-U.S. regulatory activities and
worldwide commercial activities. In the U.S., Bayer and Loxo
Oncology will co-promote the products.
About Oncology at Bayer
Bayer is committed to
delivering science for a better life by advancing a
portfolio of innovative treatments. The oncology franchise at
Bayer now includes four oncology products and several other
compounds in various stages of clinical development. Together,
these products reflect the company's approach to research, which
prioritizes targets and pathways with the potential to impact the
way that cancer is treated.
About Bayer
Bayer is a global enterprise with core competencies in the Life
Science fields of health care and agriculture. Its products and
services are designed to benefit people and improve their quality
of life. At the same time, the Group aims to create value through
innovation, growth and high earning power. Bayer is committed to
the principles of sustainable development and to its social and
ethical responsibilities as a corporate citizen. In fiscal 2017,
the Group employed around 99,800 people and had sales of
EUR 35.0 billion. Capital
expenditures amounted to EUR 2.4
billion, R&D expenses to EUR 4.5
billion. For more information, go to www.bayer.us.
© 2018 Bayer
BAYER® and the Bayer Cross are registered trademarks of
Bayer.
Media Contact:
Rose
Talarico, Tel. +1 862.404.5302
E-Mail: rose.talarico@bayer.com
Forward-Looking Statement
This news release may
contain forward-looking statements based on current assumptions and
forecasts made by Bayer Group or subgroup management. Various known
and unknown risks, uncertainties and other factors could lead to
material differences between the actual future results, financial
situation, development or performance of the company and the
estimates given here. These factors include those discussed in
Bayer's public reports which are available on the Bayer website at
www.bayer.com. The company assumes no liability whatsoever to
update these forward-looking statements or to conform them to
future events or developments.
PP-912-US-0084
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