Turning Point Therapeutics Granted Sixth Regulatory Designation for Repotrectinib
August 11 2021 - 4:01PM
Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision
oncology company developing next-generation therapies that target
genetic drivers of cancer, today announced the U.S. Food and Drug
Administration (FDA) granted a sixth regulatory designation to lead
drug candidate, repotrectinib.
The Fast-Track designation was granted for the treatment of
patients with ROS1-positive advanced non-small cell lung cancer
(NSCLC) who have been previously treated with one prior ROS1
tyrosine kinase inhibitor (TKI) and who have not received prior
platinum-based chemotherapy.
“We are pleased to receive our fourth Fast-Track designation and
sixth overall regulatory designation for repotrectinib as we
continue to work toward our goal of getting this ROS1 targeted
therapy to patients quickly,” said Athena Countouriotis, M.D.,
president and chief executive officer. “We continue to believe
repotrectinib has the potential to be a best-in-class treatment for
patients with ROS1-positive advanced non-small cell lung cancer or
NTRK-positive advanced solid tumors and now have multiple
regulatory designations in both the TKI-naïve and TKI-pretreated
ROS1 patient populations.”
Repotrectinib was previously granted Breakthrough Therapy
designation in ROS1- positive metastatic NSCLC patients who have
not been treated with a ROS1 tyrosine kinase inhibitor, as well as
three Fast-Track designations in ROS1-positive advanced NSCLC
patients who are ROS1 TKI naïve, ROS1-positive advanced NSCLC
patients who have been previously treated with one prior line of
platinum-based chemotherapy and one prior ROS1 TKI, and
NTRK-positive patients with advanced solid tumors who have
progressed following treatment with at least one prior line of
chemotherapy and one or two prior TRK TKIs and have no satisfactory
alternative treatments.
About Fast-Track DesignationFast-Track is an
FDA program intended to facilitate the development and expedite the
review of drug candidates to treat serious conditions and fill an
unmet medical need.
A drug candidate that receives Fast-Track designation may be
eligible for:
- More frequent meetings with the FDA to discuss the drug’s
development plan and ensure collection of appropriate data needed
to support drug approval;
- More frequent written communication with the FDA;
- Eligibility for Accelerated Approval and Priority Review, if
relevant criteria are met; and
- Rolling submission of a New Drug Application (NDA) for review
by FDA.
About Turning Point Therapeutics
Inc.Turning Point Therapeutics is a clinical-stage
precision oncology company with a pipeline of internally discovered
investigational drugs designed to address key limitations of
existing cancer therapies. The company’s lead drug candidate,
repotrectinib, is a next-generation kinase inhibitor targeting the
ROS1 and TRK oncogenic drivers of non-small cell lung cancer and
advanced solid tumors. Repotrectinib, which is being studied in a
registrational Phase 2 study in adults and a Phase 1/2 study in
pediatric patients, has shown antitumor activity and durable
responses among kinase inhibitor treatment-naïve and pre-treated
patients. The company’s pipeline of drug candidates also includes
TPX-0022, targeting MET, CSF1R and SRC, which is being studied in a
Phase 1 trial of patients with advanced or metastatic solid tumors
harboring genetic alterations in MET; TPX-0046, targeting RET,
which is being studied in a Phase 1/2 trial of patients with
advanced or metastatic solid tumors harboring genetic alterations
in RET; and TPX-0131, a next-generation ALK inhibitor, which is
being studied in a Phase 1/2 trial of previously treated patients
with ALK-positive advanced or metastatic non-small cell lung
cancer. Turning Point’s next-generation kinase inhibitors are
designed to bind to their targets with greater precision and
affinity than existing therapies, with a novel, compact structure
that has demonstrated an ability to potentially overcome treatment
resistance common with other kinase inhibitors. The company is
driven to develop therapies that mark a turning point for patients
in their cancer treatment. For more information,
visit www.tptherapeutics.com.
Forward Looking StatementsStatements contained
in this press release regarding matters that are not historical
facts are “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. Such
forward-looking statements include statements regarding, among
other things, the efficacy, safety and therapeutic potential of
repotrectinib, the potential benefits of Fast Track Designation and
the regulatory approval path for repotrectinib. Because such
statements are subject to risks and uncertainties, actual results
may differ materially from those expressed or implied by such
forward-looking statements. Words such as “plans”, “will”,
“believes,” “anticipates,” “expects,” “intends,” “goal,”
“potential” and similar expressions are intended to identify
forward-looking statements. These forward-looking statements are
based upon Turning Point Therapeutics’ current expectations and
involve assumptions that may never materialize or may prove to be
incorrect. Actual results could differ materially from those
anticipated in such forward-looking statements as a result of
various risks and uncertainties, which include, without limitation,
risks and uncertainties associated with Turning Point Therapeutics’
business in general, risks and uncertainties related to the impact
of the COVID-19 pandemic to Turning Point’s business and the other
risks described in Turning Point Therapeutics’ filings with
the SEC, including its quarterly report on Form 10-Q filed
with the SEC on August 9, 2021. All forward-looking
statements contained in this press release speak only as of the
date on which they were made. Turning Point
Therapeutics undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
Contact: Jim
Mazzolajim.mazzola@tptherapeutics.com858-342-8272
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