Approved indication for REVLIMID®
(lenalidomide) offers a new option for European patients with
relapsed/refractory MCL, one of the poorest prognoses among all
lymphomas
Approval gives Celgene its first opportunity to
support unmet needs of lymphoma patients across the European
Union
Celgene International Sàrl, a wholly owned subsidiary of Celgene
Corporation (NASDAQ: CELG) today announced that the European
Commission (EC) has approved REVLIMID® (lenalidomide) for
the treatment of adult patients with relapsed or refractory mantle
cell lymphoma (MCL).
MCL is a rare sub-type of aggressive non-Hodgkin’s lymphoma
(NHL), which starts in the lymph nodes but can move to other
organs, causing tumours known as lymphomas. Between 3 and 6 percent
of NHL patients have MCL. MCL has the poorest long-term survival of
all B-cell lymphoma subtypes, with fewer than 50 percent of
patients surviving at 5 years1. In Europe there were 93,433 new
cases of non-Hodgkin lymphoma, and 37,900 deaths in 20122. MCL has
a median age of onset of 70 years and affects men more often than
women3.
“New treatment options are vitally needed in order to change the
course of MCL for patients, given the severity of the disease, and
there are still limited existing treatment options,” said Prof.
Marek Trneny, Charles University in Prague. “Lenalidomide is a
proven medicine that has shown efficacy in relapsed/refractory MCL,
with the MCL-002 study meeting its primary endpoint of an
improvement in progression-free survival (PFS).”
Tuomo Pätsi, President of Celgene in Europe, Middle East and
Africa (EMEA), adds: “Today is an important milestone in the fight
to find new treatment options for patients with MCL, a
difficult-to-treat disease with a high unmet medical need. The
approval by the European Commission for REVLIMID® in
relapsed/refractory MCL gives us the opportunity to support
patients in their fight against this disease, with an innovative
treatment, and it is only the beginning of our work to support the
needs of patients with MCL. We have a robust clinical program of
lymphoma studies reaching patients across the globe with an aim to
find new treatment options across numerous types of lymphoma.”
The EC decision was based on data from MCL-002, a phase II,
multicenter, randomized open-label study to determine the efficacy
and safety of REVLIMID® versus the investigator’s choice
(IC), in 254 patients who were refractory to their last treatment
or had relapsed one to three times. In the study, REVLIMID®
showed a significant improvement in progression-free survival (PFS)
of 8.7 months vs. 5.2 in the control arm (HR = 0.61, p value of
.004)4.
In the study, the most frequently observed adverse reactions
which occurred more frequently in the REVLIMID® arm compared
with the IC arm were neutropenia (50.9%), anaemia (28.7%),
diarrhoea (22.8%), fatigue (21.0%), constipation (17.4%), pyrexia
(16.8%), and rash (16.2%).
The EC decision for the use of REVLIMID® in adult
patients with relapsed/refractory MCL follows the positive opinion
issued by the Committee for Medicinal Products for Human Use (CHMP)
earlier this year. The EC decision marks the 6th new product or
indication granted to Celgene in the last 18 months in the European
Union. In 2015, Celgene announced the EC approval of medicines for
newly diagnosed multiple myeloma, another form of blood cancer;
psoriasis and psoriatic arthritis; a specific subset of acute
myeloid leukaemia (AML) patients; and non-small-cell lung cancer
(NSCLC).
In addition to the EU approval, REVLIMID® is indicated
for the treatment of patients with relapsed/refractory MCL in the
United States, Switzerland, Israel, Turkey, Australia, and numerous
countries in Latin America. REVLIMID® is also indicated in
various countries including the EU for treatment of newly diagnosed
and relapsed/refractory multiple myeloma and myelodysplastic
syndromes.
IMPORTANT SAFETY INFORMATION
WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS
and ARTERIAL THROMBOEMBOLISM
Embryo-Fetal Toxicity
Do not use REVLIMID® during pregnancy. Lenalidomide, a
thalidomide analogue, caused limb abnormalities in a developmental
monkey study. Thalidomide is a known human teratogen that causes
severe life-threatening human birth defects. If lenalidomide is
used during pregnancy, it may cause birth defects or embryo-fetal
death. In females of reproductive potential, obtain 2 negative
pregnancy tests before starting REVLIMID® treatment. Females
of reproductive potential must use 2 forms of contraception or
continuously abstain from heterosexual sex during and for 4 weeks
after REVLIMID® treatment.
Hematologic Toxicity (Neutropenia and
Thrombocytopenia)
REVLIMID® can cause significant neutropenia and
thrombocytopenia. Eighty percent of patients with del 5q MDS had to
have a dose delay/reduction during the major study. 34% of patients
had to have a second dose delay/reduction. Grade 3 or 4 hematologic
toxicity was seen in 80% of patients enrolled in the study.
Patients on therapy for del 5q MDS should have their complete blood
counts monitored weekly for the first 8 weeks of therapy and at
least monthly thereafter. Patients may require dose interruption
and/or reduction. Patients may require use of blood product support
and/or growth factors.
Venous and Arterial
Thromboembolism
REVLIMID® has demonstrated a significantly increased risk
of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well
as risk of myocardial infarction and stroke in patients with MM who
were treated with REVLIMID® and dexamethasone therapy.
Monitor for and advise patients about signs and symptoms of
thromboembolism. Advise patients to seek immediate medical care if
they develop symptoms such as shortness of breath, chest pain, or
arm or leg swelling. Thromboprophylaxis is recommended and the
choice of regimen should be based on an assessment of the patient's
underlying risks.
About REVLIMID®
REVLIMID® is approved in Europe for the treatment of
adult patients with previously untreated multiple myeloma (MM) who
are not eligible for transplant. REVLIMID® is also approved
in combination with dexamethasone for the treatment of patients
with MM who have received at least one prior therapy in nearly 70
countries, encompassing Europe, the Americas, the Middle-East and
Asia, and in combination with dexamethasone for the treatment of
patients whose disease has progressed after one therapy in
Australia and New Zealand.
REVLIMID® is also approved in the United States, Canada,
Switzerland, Australia, New Zealand and several Latin American
countries, as well as Malaysia and Israel, for
transfusion-dependent anaemia due to low- or intermediate-1-risk
MDS associated with a deletion 5q cytogenetic abnormality with or
without additional cytogenetic abnormalities and in Europe for the
treatment of patients with transfusion-dependent anemia due to low-
or intermediate-1-risk myelodysplastic syndromes associated with an
isolated deletion 5q cytogenetic abnormality when other therapeutic
options are insufficient or inadequate.
In addition, REVLIMID® is approved in the United States
for the treatment of patients with mantle cell lymphoma (MCL) whose
disease has relapsed or progressed after two prior therapies, one
of which included bortezomib. In Switzerland, REVLIMID is indicated
for the treatment of patients with relapsed or refractory MCL after
prior therapy that included bortezomib and
chemotherapy/rituximab.
About Celgene
Celgene International Sàrl, located in Boudry, in the Canton of
Neuchâtel, Switzerland, is a wholly-owned subsidiary and
international headquarters of Celgene Corporation. Celgene
Corporation, headquartered in Summit, New Jersey, is an integrated
global pharmaceutical company engaged primarily in the discovery,
development and commercialization of innovative therapies for the
treatment of cancer and inflammatory diseases through gene and
protein regulation. For more information, please visit
www.celgene.com. Follow Celgene on Social Media:
@Celgene, Pinterest, LinkedIn and YouTube.
Forward-Looking Statements
This press release contains forward-looking statements, which
are generally statements that are not historical facts.
Forward-looking statements can be identified by the words
"expects," "anticipates," "believes," "intends," "estimates,"
"plans," "will," “outlook” and similar expressions. Forward-looking
statements are based on management’s current plans, estimates,
assumptions and projections, and speak only as of the date they are
made. We undertake no obligation to update any forward-looking
statement in light of new information or future events, except as
otherwise required by law. Forward-looking statements involve
inherent risks and uncertainties, most of which are difficult to
predict and are generally beyond our control. Actual results or
outcomes may differ materially from those implied by the
forward-looking statements as a result of the impact of a number of
factors, many of which are discussed in more detail in our Annual
Report on Form 10-K and our other reports filed with the Securities
and Exchange Commission.
All registered trademarks are owned by Celgene Corporation.
# # #
1 Leukemia and Lymphoma Society. Mantle Cell Lymphoma Facts.
July 2012.
2 http://eco.iarc.fr/EUCAN/Cancer.aspx?Cancer=38
3 Smedby KE, Hjalgrim H. Epidemiology and etiology of mantle
cell lymphoma and other non-Hodgkin lymphoma subtypes. Semin Cancer
Biol. 2011 Nov; 215:293-8.
4 Trneny, M et al. Phase II Randomized, Multicenter Study of
Lenalidomide Vs Best Investigator’s Choice in Relapsed/Refractory
Mantle Cell Lymphoma: Results of the MCL-002 (SPRINT) Study Blood
Dec 2014, 124 (21) 626;
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