Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced that it
has submitted a request to the European Medicines Agency (EMA) for
a re-examination of the negative opinion issued in January by the
EMA’s Committee For Medicinal Products for Human Use (CHMP) for
conditional approval of FOLOTYN® (pralatrexate injection) for the
treatment of patients with peripheral T-cell lymphoma (PTCL) whose
disease has progressed after at least one prior systemic therapy.
PTCL comprises a biologically diverse group of aggressive, rare
blood cancers that have a worse prognosis than most other types of
lymphoma, including B-cell lymphoma. According to current CHMP
guidelines, a final opinion on the re-examination could be issued
by the EMA within four to five months.
“We believe FOLOTYN has the potential to offer an important new
treatment option for patients with relapsed or refractory
peripheral T-cell lymphoma, an indication for which there are
currently no EMA-approved therapies and no accepted standard of
care,” said Charles Morris, MB ChB, MRCP, chief medical officer at
Allos Therapeutics. “We look forward to working closely with our
partner Mundipharma and the CHMP during the re-examination
process.”
Pralatrexate has orphan medicinal product designation in Europe
for the treatment of PTCL (nodal, other extranodal, and
leukaemic/disseminated). In the E.U., orphan medicinal product
designation is conferred upon investigational products for diseases
that affect fewer than five in 10,000 patients. Products with
orphan designation that are the first to be approved for a specific
indication, and continue to meet the requirements for orphan
designation, receive up to ten years of market exclusivity in the
E.U.
About FOLOTYN
FOLOTYN, a folate analogue metabolic inhibitor, was discovered
by Sloan-Kettering Institute for Cancer Research, SRI International
and Southern Research Institute and developed by Allos
Therapeutics. In September 2009, the U.S. Food and Drug
Administration (FDA) granted accelerated approval for FOLOTYN for
use as a single agent for the treatment of 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. FOLOTYN has
been available to patients in the U.S. since October 2009.
About Peripheral T-Cell Lymphoma
Peripheral T-cell lymphomas are a biologically diverse group of
aggressive, mature T and NK (natural killer) cell non-Hodgkin
lymphomas with similar outcomes, which include PTCL-NOS (PTCL not
otherwise specified), AITL (angioimmunoblastic T-cell lymphoma),
and ALCL (anaplastic large-cell lymphoma).1 The prognosis for
patients with PTCL is generally poor for most subtypes.2
T-cell lymphomas account for approximately 10% to 15% of all
cases of non-Hodgkin lymphomas (NHL).1-3 The majority of patients
ultimately have refractory disease to a variety of agents,
including multi-agent chemotherapy with CHOP (cyclophosphamide,
doxorubicin, vincristine, and prednisone) or CHOP-like regimens.
The 5-year overall survival rate in these patients is 25% to 40%,
depending on sub-type.4-5
About Conditional Marketing Authorisation
A conditional marketing authorisation is granted to a medicinal
product with a positive benefit/risk assessment that fulfils an
unmet medical need when the benefit to public health of immediate
availability outweighs the risk inherent in the fact that
additional data are still required. A conditional marketing
authorisation is renewable annually. As part of the conditions of a
conditional marketing authorisation for FOLOTYN, further data would
be required.
About Allos Therapeutics
Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical
company committed to the development and commercialization of
innovative anti-cancer therapeutics. Allos is currently focused on
the development and commercialization of FOLOTYN® (pralatrexate
injection), a folate analogue metabolic inhibitor. FOLOTYN is
approved in the U.S. for the treatment of patients with relapsed or
refractory PTCL. For additional information, please visit
www.allos.com.
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 and
receive vitamin B12 to potentially reduce treatment-related
hematological toxicity and mucositis.
Fatal dermatologic reactions may occur. Dermatologic reactions
may be progressive and increase in severity with further treatment.
Patients with dermatologic reactions should be monitored closely,
and if severe, FOLOTYN should be withheld or discontinued.
Tumor lysis syndrome may occur. Monitor patients and treat if
needed.
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 were mucositis (70%),
thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most
common serious adverse events are pyrexia, mucositis, sepsis,
febrile neutropenia, dehydration, dyspnea, and
thrombocytopenia.
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.
Drug Interactions
Co-administration of drugs subject to renal clearance (e.g.,
probenecid, NSAIDs, and trimethoprim/sulfamethoxazole) may result
in delayed renal clearance.
Please see FOLOTYN Full Prescribing Information at
www.FOLOTYN.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 statements regarding the Company’s request for
re-examination of the CHMP opinion; the potential to obtain
conditional approval of FOLOTYN from the EMA for the treatment of
patients with PTCL whose disease has progressed after at least one
prior systemic therapy; 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, that the design of and data collected from the
Company’s pivotal PROPEL trial may not be adequate to demonstrate
the safety and efficacy of FOLOTYN for the treatment of patients
with PTCL whose disease has progressed after at least one prior
systemic therapy, or otherwise be sufficient to support EMA
approval; and risks and uncertainties relating to the Company’s
strategic collaboration with Mundipharma, including the parties’
future product development, regulatory and commercialization
strategies. 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 September 30, 2011, 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
registered trademarks of Allos Therapeutics, Inc.
Editor’s Note: This press release is also available under the
Media section of Allos Therapeutics’ website at www.allos.com
References:
1. The Non-Hodgkin's Lymphoma Classification Project. A clinical
evaluation of the International Lymphoma Study Group classification
of non-Hodgkin's lymphoma. Blood. 1997;89(11):3909-3908.
2. Hennessy BT, Hanrahan EO, Daly PA. Non-Hodgkin lymphoma: an
update [review]. Lancet Oncol. 2004;5(6):341-353.
3. O'Leary HM, Savage KJ. Novel therapies in peripheral T-cell
lymphomas [review]. Curr Oncol Rep. 2008;134(5):202-207.
4. Savage 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.
5. Savage KJ. Peripheral T-cell Lymphomas. Blood Rev. 2007;
21:201-216.
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