Ignyta Granted Breakthrough Therapy Designation for Entrectinib by U.S. Food and Drug Administration
May 15 2017 - 7:00AM
Business Wire
Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on
precision medicine in oncology, today announced that the U.S. Food
and Drug Administration (FDA) has granted a Breakthrough Therapy
Designation (BTD) to entrectinib “for the treatment of NTRK
fusion-positive, locally advanced or metastatic solid tumors in
adult and pediatric patients who have either progressed following
prior therapies or who have no acceptable standard therapies.”
Entrectinib is the company’s investigational, orally available,
CNS-active tyrosine kinase inhibitor targeting tumors that harbor
NTRK1/2/3, ROS1, or ALK gene fusions.
The FDA’s Breakthrough Therapy Designation is intended to
expedite development and review timelines of potential new
medicines for use in the treatment of a serious or life-threatening
condition when preliminary clinical evidence indicates the drug may
demonstrate substantial improvement over available therapies on one
or more clinically significant endpoints [1].
“The granting of Breakthrough Therapy Designation enables us to
continue high quality engagement with the FDA during the
development of entrectinib, and we greatly appreciate the
commitment by FDA to move this investigational drug forward,” said
Jonathan Lim, M.D., Chairman and CEO of Ignyta. “We believe this
designation validates the broad potential of entrectinib as a novel
treatment for patients, regardless of age, with TRK-positive
tumors, a group of cancers for which there currently is no approved
treatment and which represents a clear unmet medical need.”
About Entrectinib
Entrectinib is a novel, orally available, CNS-active tyrosine
kinase inhibitor targeting tumors that harbor activating
alterations to NTRK1/2/3 (encoding TRKA/TRKB/TRKC), ROS1 or ALK.
Entrectinib is the only TRK inhibitor with clinically demonstrated
activity against primary and metastatic CNS disease, and does not
have undesirable off-target activity. This product candidate is in
a Phase 2 clinical trial called STARTRK-2, which is the second of
the “Studies of Tumor Alterations
Responsive to Targeting Receptor
Kinases.” The trial is a global,
multicenter, open label, potentially registration-enabling Phase 2
clinical trial of entrectinib that utilizes a basket design with
screening of patient tumor samples for the relevant targets. Such a
basket design takes full advantage of entrectinib’s demonstrated
preliminary clinical activity across a range of different tumor
types and molecular targets.
About Ignyta, Inc.
Blazing a New Future for Patients with
Cancer™
At Ignyta, we work tirelessly on behalf of patients with cancer
to offer potentially life-saving, precisely targeted therapeutics
(Rx) guided by companion diagnostic (Dx) tests. Our integrated
Rx/Dx strategy allows us to enter uncharted territory, illuminating
the molecular drivers of cancer and quickly advancing treatments to
address them. This approach embraces even those patients with the
rarest cancers, who have the highest unmet need and who may
otherwise not have access to effective treatment options. With our
pipeline of potentially first-in-class or best-in-class precision
medicines, we are pursuing the ultimate goal of not just shrinking
tumors, but eradicating cancer relapse and recurrence in precisely
defined patient populations.
For more information, please visit: www.ignyta.com.
Forward-Looking Statements
This press release contains forward-looking statements as that
term is defined in Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Statements in
this press release that are not purely historical are
forward-looking statements. Such forward-looking statements
include, among other things, references to Ignyta’s ability to
successfully conduct clinical trials for its product candidates,
the impact of entrectinib breakthrough therapy designation on
Ignyta’s interactions with FDA and the FDA’s commitment to the
advancement of entrectinib. Actual results could differ from those
projected in any forward-looking statements due to numerous
factors. Such factors include, among others, the inherent
uncertainties associated with developing new products or
technologies and operating as a development stage company; Ignyta’s
ability to develop, initiate or complete preclinical studies and
clinical trials for, obtain approvals for and commercialize any of
its product candidates; changes in Ignyta’s plans to develop and
commercialize its product candidates; the potential for final
results of the ongoing clinical trials of entrectinib or other
product candidates, or any future clinical trials of entrectinib or
other product candidates, to differ from preliminary or expected
results; Ignyta’s ability to raise any additional funding it will
need to continue to pursue its business and product development
plans; regulatory developments in the United States and foreign
countries; Ignyta’s ability to obtain and maintain intellectual
property protection for its product candidates; the risk that
orphan drug exclusivity may not effectively protect a product from
competition and that such exclusivity may not be maintained; the
potential for the company to fail to maintain the CAP accreditation
and CLIA certification of its diagnostic laboratory; the loss of
key scientific or management personnel; competition in the industry
in which Ignyta operates; and market conditions. These
forward-looking statements are made as of the date of this press
release, and Ignyta assumes no obligation to update the
forward-looking statements, or to update the reasons why actual
results could differ from those projected in the forward-looking
statements. Investors should consult all of the information set
forth herein and should also refer to the risk factor disclosure
set forth in the reports and other documents the company files with
the SEC available at www.sec.gov, including without limitation
Ignyta’s Annual Report on Form 10-K for the year ended December 31,
2016, and subsequent Quarterly Reports on Form 10-Q.
References
[1] U.S. Food and Drug Administration Safety and Innovation Act.
Available at:
http://www.gpo.gov/fdsys/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf
Accessed May 12, 2017.
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version on businesswire.com: http://www.businesswire.com/news/home/20170515005472/en/
Ignyta, Inc.Jacob Chacko, M.D., 858-255-5959CFOjc@ignyta.com
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