Allos Therapeutics, Inc. (Nasdaq:ALTH) today announced that last
night the U.S. Food and Drug Administration (FDA) granted
accelerated approval for FOLOTYNTM (pralatrexate injection) for use
as a single agent for the treatment of patients with relapsed or
refractory peripheral T-cell lymphoma (PTCL). FOLOTYN is the first
and only drug approved by the FDA for this indication and
represents a new treatment option for patients with relapsed or
refractory PTCL. This indication is based on overall response rate.
Clinical benefit such as improvement in progression free survival
or overall survival has not been demonstrated. Allos expects to
make FOLOTYN available to patients in the U.S. in October.
“Individuals with peripheral T-cell lymphoma have a very poor
prognosis and almost always relapse or become refractory to initial
therapy.1 As a result, there is an urgent need for new therapies to
treat patients with this challenging disease. FOLOTYN has
demonstrated its efficacy and safety in the PROPEL clinical trial,
and I believe it will be a welcome addition for physicians who
treat patients with relapsed or refractory PTCL,” stated Owen A.
O'Connor, MD, PhD, principal investigator in the PROPEL study of
FOLOTYN; deputy director for Clinical Research and Cancer
Treatment, NYU Cancer Institute; chief, Division of Hematologic
Malignancies and Medical Oncology; professor of Medicine and
Pharmacology at the NYU Langone Medical Center.
PTCL comprises a biologically diverse group of aggressive blood
cancers that has a poor prognosis.2 The Company’s New Drug
Application (NDA) for FOLOTYN was based on data from the PROPEL
trial. The Company believes PROPEL is the largest prospective,
multicenter, international trial ever conducted in patients with
relapsed or refractory PTCL.
“We are enthusiastic about providing this new therapy to
patients with relapsed or refractory PTCL,” said Paul L. Berns,
president and chief executive officer at Allos Therapeutics, Inc.
“The approval of FOLOTYN is a transformative event for Allos
representing our first U.S. indication. We thank the many patients
and clinical investigators who participated in the PROPEL study.
Moving forward, we plan to continue advancing the FOLOTYN clinical
development program.”
“Aggressive peripheral T-cell lymphomas have been a largely
ignored group of diseases,” said James O. Armitage, MD, The Joe
Shapiro Professor of Medicine, Department of Internal Medicine,
University of Nebraska Medical Center. “It is exciting to have the
first FDA-approved therapy for relapsed or refractory peripheral
T-cell lymphoma.”
Allos is dedicated to patient access and has established a
patient assistance program named ASAP (Allos Support for Assisting
Patients) to provide reimbursement support. Commencing in October,
more information regarding ASAP will be available by calling the
Hotline at 1-877-ASAP102 (272-7102), Monday to Friday, 8 a.m. to 7
p.m. Central Time or by visiting www.getASAPinfo.com.
“The approval of FOLOTYN brings a new treatment option to
patients afflicted with peripheral T-cell lymphoma,” said Peter L.
Saltonstall, president and chief executive officer of the National
Organization for Rare Disorders (NORD). “We at NORD are excited
about this approval and will continue our efforts to focus national
attention on rare diseases and on the fact that most rare diseases
have no FDA-approved treatment at this time.”
In connection with the accelerated approval, Allos has agreed to
undertake additional clinical studies to further verify and
describe the clinical benefit of FOLOTYN in patients with T-cell
lymphoma.
FOLOTYN was discovered by Sloan-Kettering Institute for Cancer
Research, SRI International and Southern Research Institute and
developed by Allos Therapeutics.
About PROPEL
The FOLOTYN approval was based on the results from PROPEL, an
open-label, single-arm, multi-center, international clinical trial
that enrolled 115 patients with relapsed or refractory PTCL, 109 of
whom were considered evaluable for efficacy according to the trial
protocol. Patients were considered evaluable if they received at
least one dose of FOLOTYN, their diagnosis of PTCL was confirmed by
independent pathology review, and they had relapsed or refractory
disease after at least one prior treatment. Patients were treated
with FOLOTYN at 30 mg/m2 once weekly by IV push over 3-5 minutes
for 6 weeks in 7-week cycles until disease progression or
unacceptable toxicity. In addition, patients received 1mg of
vitamin B12 intramuscularly every 8-10 weeks and 1.0-1.25 mg of
folic acid orally on a daily basis.
The primary efficacy endpoint was overall response rate
(complete response, complete response unconfirmed and partial
response) as assessed by International Workshop Criteria (IWC). The
key secondary efficacy endpoint was duration of response. Response
assessments were scheduled at the end of cycle 1 and then every
other cycle (every 14 weeks). Duration of response was measured
from the first day of documented response to disease progression or
death. Response and disease progression were evaluated by
independent central review using the IWC.
The results of the trial demonstrated that 29 of 109 evaluable
patients, or 27%, responded to FOLOTYN. The median duration of
response was 287 days, or 9.4 months (range 1-503 days). Thirteen
of 109 evaluable patients had a duration of response ≥ 14 weeks
(range 98-503 days). The most common grade 3/4 adverse events were
thrombocytopenia, which was observed in 33% of patients; mucositis
in 21% of patients; neutropenia in 20% of patients; and anemia in
17% of patients. See below for Important Safety Information.
The median number of prior systemic therapies was 3 (range
1-12). Approximately one-fourth of patients (24%, n = 27) did not
have evidence of response to any previous therapy. Approximately
two-thirds of patients (63%, n = 70) did not have evidence of
response to their most recent prior therapy before entering the
trial. The initial response assessment was scheduled at the end of
cycle 1. Of the responders, 66% responded within cycle 1. The
median time to first response was 45 days (range 37-349 days).
Important Safety Information
Warnings and Precautions:
FOLOTYN may suppress bone marrow function, manifested by
thrombocytopenia, neutropenia, and anemia. Monitor blood counts and
omit or modify dose for hematologic toxicities.
Mucositis may occur. If ≥ Grade 2 mucositis is observed, omit or
modify dose.
Patients should be instructed to take folic acid (1.0 -1.25 mg
orally on a daily basis) and receive vitamin B12 (1 mg
intramuscularly every 8-10 weeks) to potentially reduce
treatment-related hematological toxicity and mucositis.
FOLOTYN can cause fetal harm. Women should avoid becoming
pregnant while being treated with FOLOTYN, and pregnant women
should be informed of the potential harm to the fetus.
Use caution and monitor patients when administering FOLOTYN to
patients with moderate to severe renal function impairment.
Elevated liver function test abnormalities may occur and require
monitoring. If liver function test abnormalities are ≥ Grade 3,
omit or modify dose.
Adverse Reactions:
The most common adverse reactions observed in PROPEL were
mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue
(36%). The most common serious adverse events (>3%),
regardless of causality, were pyrexia, mucositis, sepsis, febrile
neutropenia, dehydration, dyspnea and thrombocytopenia. Forty-four
percent of patients experienced a serious adverse event while on
study or within 30 days after their last dose of FOLOTYN.
Twenty-three percent of patients discontinued treatment due to
adverse reactions.
Drug Interactions:
Co-administration of drugs subject to renal clearance (e.g.,
probenecid, NSAIDs, and trimethoprim/sulfamethaxazole) may result
in delayed renal clearance.
Use in Specific Patient Population:
Nursing mothers should be advised to discontinue nursing or the
drug, taking into consideration the importance of the drug to the
mother.
For additional important safety information, please see the full
prescribing information for
FOLOTYN at www.allos.com.
Conference Call and Webcast Information
Allos will host a webcast conference call on Friday, September
25, 2009 at 9:00 a.m. ET. Participants can access the call at
877-941-8631 (U.S. and Canada) or +480-629-9820
(international). To access the live audio webcast or the
subsequent archived recording, visit the “Investors - Presentations
and Events” section of the Company’s website at www.allos.com.
Webcast and telephone replays of the conference call will be
available approximately two hours after the completion of the
call. Callers can access the replay by dialing 800-406-7325
(domestic) or 303-590-3030 (international). The passcode is
4164756#. The webcast will be recorded and available for replay on
the Company's website until October 7, 2009.
About Allos Therapeutics
Allos Therapeutics, Inc. (Nasdaq:ALTH) is a biopharmaceutical
company committed to the development and commercialization of
innovative anti-cancer therapeutics. FOLOTYN is the first and only
drug approved in the U.S. for the treatment of patients with
relapsed or refractory peripheral T-cell lymphoma. Allos is also
developing FOLOTYN in other potential indications. Allos retains
exclusive worldwide rights to FOLOTYN for all indications. The
Company is headquartered in Westminster, CO. For additional
information, please visit www.allos.com.
Safe Harbor Statement
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Such forward-looking
statements include the Company’s statements regarding the potential
for FOLOTYN to offer an important new treatment option or become a
new standard for patients with relapsed or refractory PTCL; the
Company’s anticipated timeline for making FOLOTYN available to
patients in the U.S.; the Company’s intent to advance the FOLOTYN
clinical development program; and other statements that are other
than statements of historical facts. In some cases, you can
identify forward-looking statements by terminology such as “may,”
“will,” “should,” “expects,” “intends,” “plans,” “anticipates,”
“believes,” “estimates,” “predicts,” “projects,” “potential,”
“continue,” and other similar terminology or the negative of these
terms, but their absence does not mean that a particular statement
is not forward-looking. Such forward-looking statements are not
guarantees of future performance and are subject to risks and
uncertainties that may cause actual results to differ materially
from those anticipated by the forward-looking statements. Important
factors that may cause actual results to differ materially include,
but are not limited to, the risks and uncertainties associated with
developing adequate sales, marketing and distribution capabilities;
the acceptance of FOLOTYN in the marketplace; the status of
reimbursement from third party payors; the Company’s dependence on
third party manufacturers; the Company’s compliance with applicable
regulatory requirements, including the healthcare fraud and abuse
laws and the Company’s post-marketing requirements; and the
Company’s access to capital to support its future operations,
including product development and commercialization plans for
FOLOTYN. Additional information concerning these and other factors
that may cause actual results to differ materially from those
anticipated in the forward-looking statements is contained in the
"Risk Factors" section of the Company's Quarterly Report on Form
10-Q for the quarter ended June 30, 2009, and in the Company's
other periodic reports and filings with the Securities and Exchange
Commission. The Company cautions investors not to place undue
reliance on the forward-looking statements contained in this press
release. All forward-looking statements are based on information
currently available to the Company on the date hereof, and the
Company undertakes no obligation to revise or update these
forward-looking statements to reflect events or circumstances after
the date of this presentation, except as required by law.
Note: The Allos logo and FOLOTYN name are trademarks of Allos
Therapeutics, Inc.
References:
1Savage KJ, Chhanabhai M, Gascoyne RD, et al. Characterization
of peripheral T-cell lymphomas in a single North American
institution by the WHO classification. Ann Oncol
2004;15(10):1467-75.
2Armitage J, Vose J, Weisenburger D. International peripheral
T-cell and natural killer/T-cell lymphoma study: pathology findings
and clinical outcomes. J Clin Oncol 2008;26(25):4124-30.
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