ARIAD Completes Rolling Submission of New Drug Application for Brigatinib to the U.S. Food and Drug Administration
August 30 2016 - 7:35AM
Business Wire
ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced it has
completed the rolling submission of the New Drug Application (NDA)
for its investigational anaplastic lymphoma kinase (ALK) inhibitor,
brigatinib, to the U.S. Food and Drug Administration (FDA). ARIAD
is seeking U.S. marketing approval of brigatinib for patients with
metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC)
who are resistant or intolerant to crizotinib. The Company is
seeking accelerated approval for brigatinib from the FDA and has
requested a priority review of the application, which, if granted,
would allow for approval of brigatinib eight months after the NDA
submission, as opposed to 12 months for a standard review.
“Many patients with ALK-positive non-small cell lung cancer
eventually develop disease progression,” said Corey Langer, M.D.,
director of thoracic oncology in the Abramson Cancer Center of the
University of Pennsylvania and a professor of Hematology-Oncology
in Penn’s Perelman School of Medicine. “We are excited that the
brigatinib NDA submission is now complete and are hopeful that
brigatinib’s data, including the observation of complete responses
and activity in the central nervous system, will provide patients
and their oncologists with a new treatment option.”
ARIAD’s NDA submission includes clinical data from its Phase 1/2
and pivotal Phase 2 ALTA trials of brigatinib. Data from the ALTA
trial, in which patients who had experienced disease progression on
crizotinib therapy were randomized to one of two brigatinib
regimens, were presented at the 2016 Meeting of the American
Society of Clinical Oncology (ASCO). With a median follow-up of 8.3
months, the data show that, for patients treated with the 180 mg
regimen with a seven day lead-in at 90 mg (Arm B), 54 percent
achieved an investigator-assessed confirmed objective response, the
trial’s primary endpoint. In this arm, the median progression free
survival (PFS) exceeded one year (12.9 months). Additionally, a 67%
confirmed intracranial objective response rate was achieved in
patients with measurable brain metastases. The most common
treatment-emergent adverse events (TEAEs; ≥ 25% of all patients in
Arm B), regardless of relationship to treatment, were nausea (40%),
diarrhea (38%), cough (34%), increased blood creatine phosphokinase
(30%), headache (27%) and fatigue (27%). TEAEs, ≥ grade 3,
occurring in ≥ 5 percent of all patients in Arm B, were increased
blood creatine phosphokinase (9%), hypertension (6%) and pneumonia
(5%). A subset of pulmonary adverse events with early onset
(median: Day 2; range: Day 1-9) occurred in 6 percent of all
patients (≥ grade 3 in 3% of patients); no such events with early
onset occurred after dose escalation to 180 mg QD in Arm B.
“With the completion of the brigatinib submission this week, we
are excited by its potential, if approved, to offer additional hope
to patients and their families,” stated Paris Panayiotopoulos,
president and chief executive officer of ARIAD. “We are thankful to
the patients and physicians who participated in the clinical trials
of brigatinib. We remain grateful to the FDA for granting
brigatinib a breakthrough designation and the benefit of a rolling
submission process, unique to the U.S. regulatory system.”
Brigatinib received Breakthrough Therapy designation from the
FDA for the treatment of patients with ALK+ NSCLC whose tumors are
resistant to crizotinib, and was granted orphan drug designation by
the FDA for the treatment of ALK+ NSCLC. ARIAD plans to submit a
Marketing Authorization Application (MAA) for brigatinib to the
European Medicines Agency (EMA) in early 2017.
About Brigatinib
Brigatinib is an investigational, targeted cancer medicine
discovered internally at ARIAD. It is in development for the
treatment of patients with anaplastic lymphoma kinase positive
(ALK+) non-small cell cancer (NSCLC). The global Phase 2 ALTA trial
is the basis for brigatinib’s initial regulatory review. ARIAD has
also initiated the Phase 3 ALTA 1L trial to assess the efficacy and
safety of brigatinib in comparison to crizotinib in patients with
locally advanced or metastatic ALK+ NSCLC who have not received
prior treatment with an ALK inhibitor. More information on
brigatinib clinical trials, including the expanded access program
(EAP) for ALK+ NSCLC can be found here.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts, is focused on discovering, developing and
commercializing precision therapies for patients with rare cancers.
ARIAD is working on new medicines to advance the treatment of rare
forms of chronic and acute leukemia, lung cancer and other rare
cancers. ARIAD utilizes computational and structural approaches to
design small-molecule drugs that overcome resistance to existing
cancer medicines. For additional information, visit
http://www.ariad.com or follow ARIAD on Twitter
(@ARIADPharm).
Editor’s note: Dr. Langer has received consulting fees from
ARIAD.
Forward-Looking Statements
This press release contains forward-looking statements, each of
which are qualified in their entirety by this cautionary statement.
Any statements contained herein which do not describe historical
facts, including, but not limited to the statements about the
anticipated timing for potential regulatory approval of brigatinib
in the United States, the potential for brigatinib to provide a new
treatment option to ALK+ NSCLC patients, the Company’s plans to
file for regulatory approval of brigatinib with the EMA, and the
Company’s ongoing clinical development of brigatinib, are
forward-looking statements that are based on management’s
expectations and are subject to certain factors, risks and
uncertainties that may cause actual results, outcome of events,
timing and performance to differ materially from those expressed or
implied by such statements. These factors, risks and uncertainties
include, but are not limited to, our ability to successfully
commercialize and generate profits from sales of Iclusig and our
product candidates, if approved; competition from alternative
therapies; our ability to meet anticipated clinical trial
commencement, enrollment and completion dates and regulatory filing
dates for our products and product candidates and to move new
development candidates into the clinic; our ability to execute on
our key corporate initiatives; regulatory developments and safety
issues, including difficulties or delays in obtaining regulatory
and pricing and reimbursement approvals to market our products; our
reliance on the performance of third-party manufacturers and
specialty pharmacies for the supply and distribution of our
products and product candidates; the occurrence of adverse safety
events with our products and product candidates; the costs
associated with our research, development, manufacturing,
commercialization and other activities; the conduct, timing and
results of preclinical and clinical studies of our products and
product candidates, including that preclinical data and early-stage
clinical data may not be replicated in later-stage clinical
studies; the adequacy of our capital resources and the availability
of additional funding; the ability to satisfy our contractual
obligations, including under our leases, convertible debt and
royalty financing agreements; patent protection and third-party
intellectual property claims; litigation; our operations in foreign
countries; risks related to key employees, markets, economic
conditions, health care reform, prices and reimbursement rates; and
other risk factors detailed in our public filings with the U.S.
Securities and Exchange Commission, including our most recent
Annual Report on Form 10-K and subsequent Quarterly Reports on Form
10-Q. Except as otherwise noted, these forward-looking statements
speak only as of the date of this press release and we undertake no
obligation to update or revise any of these statements to reflect
events or circumstances occurring after this press release. We
caution investors not to place considerable reliance on the
forward-looking statements contained in this press release.
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ARIAD Pharmaceuticals, Inc.Investors:Manmeet S.
Soni, 617-503-7298Manmeet.soni@ariad.comorMedia:Liza Heapes,
617-621-2315Liza.heapes@ariad.com
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