– PDUFA date set for November 26, 2018 –
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 accepted the company’s
New Drug Application (NDA) and granted Priority Review for
larotrectinib 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).
“We are excited the larotrectinib NDA has been
accepted by FDA and granted Priority Review status,” said Josh
Bilenker, M.D., chief executive officer of Loxo Oncology.
“Larotrectinib marks an important shift towards treating cancer
based on the tumor’s genetics rather than its site of origin in the
body.”
The FDA grants Priority Review for the
applications of medicines that, if approved, would provide
significant improvements in the safety or effectiveness of the
treatment, diagnosis, or prevention of serious conditions when
compared to standard applications. Larotrectinib has also been
granted Breakthrough Therapy Designation, Rare Pediatric Disease
Designation and Orphan Drug Designation by the FDA.
Loxo Oncology and Bayer are engaged in a
collaboration for the development and commercialization of
larotrectinib. Bayer plans to submit a Marketing Authorization
Application (MAA) in the European Union in 2018.
About Larotrectinib
(LOXO-101)Larotrectinib is an oral and highly 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, 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 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 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., 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 CancerTRK
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.
It may affect greater than 60 percent of both adult and pediatric
patients with certain rare tumor types, such as secretory breast,
secretory salivary gland and infantile fibrosarcoma. 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 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, 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 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, including Loxo Oncology’s
expectations regarding the timing regulatory approval for
larotrectinib and the timing and success of any commercial
activities related to larotrectinib. 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. 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 Rahmer Endurance Advisors, LLC
415-515-9763 prahmer@enduranceadvisors.com
Media:Dan Budwick1AB
Media973-271-6085dan@1abmedia.com
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