Ignyta Receives FDA Orphan Drug Designation for Entrectinib for Treatment of NTRK Fusion-Positive Solid Tumors
July 10 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 orphan drug designation
to entrectinib for “treatment of NTRK fusion-positive solid
tumors.” NTRK fusions are molecular alterations that occur in a
broad variety of adult and pediatric solid tumor types. 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.
About Orphan Drug Designation
Under the FDA’s Orphan Drug Designation program, orphan drug
designation is granted by the FDA to novel drugs or biologics that
treat rare diseases or conditions affecting fewer than 200,000
patients in the U.S. The designation allows the drug developer to
be eligible for a seven-year period of U.S. marketing exclusivity
upon approval of the drug, as well as tax credits for clinical
research costs, the ability to apply for annual grant funding,
clinical trial design assistance, and the waiver of Prescription
Drug User Fee Act (PDUFA) filing fees.
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 has not
shown 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 potential for Ignyta to receive FDA approval for entrectinib,
and the potential benefits of orphan drug designation. 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170710005477/en/
Ignyta, Inc.Jacob Chacko, M.D.CFO858-255-5959jc@ignyta.com
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