Cascadian Therapeutics Receives Pediatric Investigation Plan Waiver from the European Medicines Agency
02 Janeiro 2018 - 11:30AM
Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage
biopharmaceutical company, today announced that it received a
product-specific pediatric waiver from the European Medicines
Agency (EMA) for tucatinib, Cascadian’s lead product candidate,
which is currently in a pivotal clinical trial for the treatment of
HER2+ metastatic breast cancer.
“This pediatric waiver is another important milestone in the
European regulatory process, and will allow Cascadian to submit a
marketing authorization application for tucatinib for the treatment
of HER2+ metastatic breast cancer to the EMA following completion
of the HER2CLIMB pivotal trial, without the requirement to conduct
clinical studies in the pediatric population prior to approval or
post-approval,” said Scott D. Myers, President and Chief Executive
Officer of Cascadian Therapeutics. As part of the regulatory
process for the registration of new medicines with the EMA,
pharmaceutical companies are required to have in place an approved
Pediatric Investigation Plan (PIP) prior to MAA filing that
outlines the clinical development strategy for studying the
investigational product in the pediatric population. In some
instances, a waiver from required pediatric studies for certain
conditions may be granted by the EMA when development of a medicine
for use in children is not feasible or appropriate.
In July 2017, Cascadian received confirmation from the EMA that
positive results from the HER2CLIMB pivotal trial could serve as a
single registrational trial for submission of an MAA to the EMA for
potential marketing approval. Cascadian received similar
confirmation from the U.S. Food and Drug Administration (FDA) in
2016. The FDA has granted tucatinib orphan drug designation for the
treatment of breast cancer patients with brain metastases.
Tucatinib has also received Fast Track designation for the
treatment of advanced HER2+ metastatic breast cancer from the
FDA.
About Cascadian TherapeuticsCascadian
Therapeutics is a clinical-stage biopharmaceutical company
dedicated to developing innovative product candidates for the
treatment of cancer. Its lead product candidate, tucatinib, is an
investigational oral, selective small molecule HER2 inhibitor.
Cascadian Therapeutics is conducting a randomized, double-blind,
controlled pivotal clinical trial called HER2CLIMB, which is
comparing tucatinib vs. placebo, each in combination with
capecitabine and trastuzumab, in patients with locally advanced or
metastatic HER2+ breast cancer with and without brain metastases,
who have previously been treated with trastuzumab, pertuzumab and
T-DM1. Additional details on HER2CLIMB can be found at
www.HER2CLIMB.com or www.clinicaltrials.gov. Tucatinib is also
being studied in other cancers through investigator initiated
studies, including HER2+ metastatic colorectal cancer and earlier
lines of HR+/HER2+ metastatic breast cancer. For more information,
please visit www.cascadianrx.com.Forward-Looking
StatementsIn order to provide Cascadian Therapeutics'
investors with an understanding of its current results and future
prospects, this release contains statements that are
forward-looking. Any statements contained in this press release
that are not statements of historical fact may be deemed to be
forward-looking statements. Words such as "believes,"
"anticipates," "plans," "expects," "will," "intends," "potential,"
"possible" and similar expressions are intended to identify
forward-looking statements. These forward-looking statements
include Cascadian Therapeutics' expectations regarding clinical
development activities, HER2CLIMB enrollment, timing of additional
data, potential benefits of its product candidates, and its use and
adequacy of cash reserves and future financings and financial
results.Forward-looking statements involve risks and uncertainties
related to Cascadian Therapeutics' business and the general
economic environment, many of which are beyond its control. These
risks, uncertainties and other factors could cause Cascadian
Therapeutics' actual results to differ materially from those
projected in forward-looking statements, including the risks
associated with the costs and expenses of developing its product
candidates, the adequacy of financing and cash, cash equivalents
and investments, changes in general accounting policies, general
economic factors, achievement of the results it anticipates from
its preclinical development and clinical trials of its product
candidates, the receipt of regulatory approvals, its ability to
adequately obtain and protect its intellectual property rights, and
other factors discussed under the caption “Risk Factors” in
Cascadian Therapeutics’ Quarterly Report on Form 10-Q for the
quarterly period ended September 30, 2017 filed with the Securities
and Exchange Commission. Although Cascadian Therapeutics believes
that the forward-looking statements contained herein are reasonable
as of the date hereof, it can give no assurance that its
expectations are correct. All forward-looking statements are
expressly qualified in their entirety by this cautionary statement.
For a detailed description of Cascadian Therapeutics' risks and
uncertainties, you should review the documents filed by Cascadian
Therapeutics with the securities regulators in the United States on
EDGAR and in Canada on SEDAR. Cascadian Therapeutics does not
undertake any obligation to publicly update its forward-looking
statements based on events or circumstances after the date hereof,
except to the extent required by law. Source: Cascadian
Therapeutics, Inc.
Contact:Cascadian TherapeuticsMonique
Greer206-801-2107mgreer@cascadianrx.com
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