Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced that the
European Medicines Agency (EMA) Committee for Medicinal Products
for Human Use (CHMP) has issued an opinion recommending against
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.
The Company plans to submit a request for re-examination of the
CHMP opinion within two weeks.
“We are committed to making FOLOTYN available in the EU for
patients with relapsed or refractory peripheral T-cell lymphoma --
an aggressive and progressive disease where there remains a high
unmet need for new therapies,” said Charles Morris, MB ChB, MRCP,
chief medical officer at Allos Therapeutics. “We continue to
believe that the available data for FOLOTYN meet the criteria for
conditional approval, and we intend to work closely with our
partner Mundipharma and the CHMP during the re-examination process.
PTCL is an indication for which there are currently no approved
therapies in Europe and no accepted standard of care.”
In May 2011, Allos entered into a strategic collaboration
agreement with Mundipharma International Corporation Limited
(Mundipharma) to co-develop FOLOTYN globally. Under the agreement,
Allos retains full commercialization rights for FOLOTYN in the
United States and Canada, with Mundipharma having exclusive rights
to commercialize FOLOTYN in all other countries. To date,
Mundipharma has submitted applications seeking regulatory approval
of FOLOTYN in Australia, S. Korea and Switzerland.
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.
For further details about the CHMP opinion on FOLOTYN, please
visit the EMA website www.ema.europa.eu/ema.
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 PrecautionsFOLOTYN 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 ReactionsThe 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 PopulationNursing mothers should
be advised to discontinue nursing or the drug, taking into
consideration the importance of the drug to the mother.
Drug InteractionsCo-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 intent to
submit a 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:
- 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.
- Hennessy BT, Hanrahan EO, Daly PA.
Non-Hodgkin lymphoma: an update [review]. Lancet Oncol.
2004;5(6):341-353.
- O'Leary HM, Savage KJ. Novel therapies
in peripheral T-cell lymphomas [review]. Curr Oncol Rep.
2008;134(5):202-207.
- 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.
- Savage KJ. Peripheral T-cell Lymphomas.
Blood Rev. 2007; 21:201-216.
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