REVLIMID® and rituximab (R2) has the potential
to become a chemotherapy-free combination treatment option for
patients with follicular lymphoma who have relapsed or did not
respond to previous treatment
The positive opinion was based on the results
of the Phase 3 AUGMENT study, which showed the R2 regimen conferred
a statistically significantly improvement in progression-free
survival versus rituximab monotherapy
Celgene Corporation (NASDAQ:CELG) today announced that the
European Medicines Agency's (EMA) Committee for Medicinal Products
for Human Use (CHMP) has adopted a positive opinion, recommending
the approval of REVLIMID® (lenalidomide) in combination with
rituximab (anti-CD20 antibody) (R²) for the treatment of adult
patients with previously treated follicular lymphoma (FL) (Grade
1-3a). If approved by the European Commission (EC), R2 will be the
first combination treatment regimen for patients with FL that does
not include chemotherapy.
“Since its initial approval in 2007, REVLIMID has continued to
demonstrate its benefits across a range of serious blood disorders
in Europe and a CHMP positive opinion for this combination with
rituximab is very good news for patients with follicular lymphoma.
We look forward to the European Commission decision,” said Tuomo
Pätsi, President of Hematology/Oncology for Celgene Worldwide
Markets.
In FL, a subtype of indolent NHL, the immune system is not
functioning optimally.1,2 When this dysfunction occurs, the immune
system either fails to detect or attack cancerous cells.1,2
Rituximab is a monoclonal antibody that targets the CD 20 antigen
on the surface of pre-B and mature B-lymphocytes. Upon binding to
CD20, rituximab causes B-cell lysis. Lenalidomide is an
immunomodulator that increases the number and activation of T and
natural killer (NK) cells, resulting in the lysis of tumor cells.
The R2 combination regimen acts by complementary mechanisms to help
the patient’s immune system to find and destroy the cancer
cells.3
Given the incurable nature of FL2, a high unmet medical need
exists for the development of novel treatment options with new
mechanisms of action and a tolerable safety profile to help improve
progression-free survival (PFS) especially in the setting of
previously treated FL.
The estimated incidence of NHL in Europe was 100,055 cases in
2018; FL accounts for approximately 25% of all NHL cases and is the
most common form of indolent NHL.3,4,5
“Chemotherapy is a standard of care for indolent forms of NHL,
but most patients will relapse or become refractory to their
current treatment,” said Prof. John Gribben, President of EHA and
Centre for Haemato-Oncology, Barts Cancer Institute, in England
“The combination of REVLIMID and rituximab could represent a new,
chemotherapy-free treatment option for patients with previously
treated follicular lymphoma.”
The CHMP positive opinion is based primarily on results from the
randomized, multi-center, double-blind, Phase 3 AUGMENT study,
which evaluated the efficacy and safety of the R² combination
versus rituximab plus placebo in patients with previously treated
FL (n=295).6,7 Additionally, findings from the MAGNIFY study were
included as support for the safety and the efficacy of lenalidomide
plus rituximab in patients with relapsed or refractory FL,
including rituximab refractory FL patients.8
The CHMP reviews applications for all member states of the
European Union (EU), as well as Norway, Liechtenstein, and Iceland.
The European Commission, which generally follows the recommendation
of the CHMP, is expected to make its final decision in
approximately two months. If approval is granted, detailed
conditions for the use of this product will be described in the
REVLIMID Summary of Product Characteristics (SmPC), which will be
published in the revised European Public Assessment Report
(EPAR).
About Follicular Lymphoma
Lymphoma is a blood cancer that develops in lymphocytes, a type
of white blood cell in the immune system that helps protect the
body from infection.9 There are two classes of lymphoma – Hodgkin’s
lymphoma and non-Hodgkin’s lymphoma (NHL) – each with specific
subtypes that determine how the cancer behaves, spreads and should
be treated.3,10,11 Other differentiating factors of lymphomas are
what type of lymphocyte is affected (T cell or B cell) and how
mature the cells are when they become cancerous.11
Follicular lymphoma is the most common indolent (slow-growing)
form of NHL, accounting for approximately 25% of all Non-Hodgkin
lymphoma (NHL) patients.5,12 Most patients present with advanced
disease usually when lymphoma-related symptoms appear (e.g., nodal
disease, B symptoms, cytopenia) and receive systemic
chemoimmunotherapy.5 While follicular lymphoma patients are
generally responsive to initial treatment, the disease course is
characterized by recurrent relapses over time with shorter
remission periods.13
About AUGMENT
AUGMENT is a Phase 3, randomized, double-blind clinical trial
evaluating the efficacy and safety of REVLIMID® (lenalidomide) in
combination with rituximab (R²) versus rituximab plus placebo in
patients with previously treated follicular lymphoma (FL). AUGMENT
included patients diagnosed with Grade 1, 2 or 3a FL, who were
previously treated with at least 1 prior systemic therapy and two
previous doses of rituximab. Patients were documented relapsed,
refractory or progressive disease following systemic therapy, but
were not rituximab-refractory.6,7
The primary endpoint was progression-free survival, defined as
the time from date of randomization to the first observation of
disease progression or death due to any cause. Secondary and
exploratory endpoints included overall response rate, durable
complete response rate, complete response rate, duration of
response, duration of complete response, overall survival,
event-free survival and time to next anti-lymphoma therapy.6,7
About REVLIMID®
REVLIMID is approved in Europe and the United States as
monotherapy, indicated for the maintenance treatment of adult
patients with newly diagnosed multiple myeloma (MM) who have
undergone autologous stem cell transplantation. REVLIMID as
combination therapy is approved in Europe, in the United States, in
Japan and in around 25 other countries for the treatment of adult
patients with previously untreated 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
myelodysplastic syndromes (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 MDS
associated with an isolated deletion 5q cytogenetic abnormality
when other therapeutic options are insufficient or inadequate.
In addition, REVLIMID is approved in Europe for the treatment of
patients with mantle cell lymphoma (MCL) and in the United States
for the treatment of patients with 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.
REVLIMID is not indicated and is not recommended for the
treatment of patients with chronic lymphocytic leukemia (CLL)
outside of controlled clinical trials.
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. To avoid embryo-fetal exposure to
lenalidomide, REVLIMID is only available through a restricted
distribution program, the REVLIMID REMS® program.
Information about the REVLIMID REMS® program is
available at www.celgeneriskmanagement.com or by calling the
manufacturer’s toll-free number 1-888-423-5436.
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. Thirty-four
percent 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.
CONTRAINDICATIONS
Pregnancy: REVLIMID can cause fetal harm when
administered to a pregnant female and is contraindicated in females
who are pregnant. If this drug is used during pregnancy or if the
patient becomes pregnant while taking this drug, the patient should
be apprised of the potential risk to the fetus
Severe Hypersensitivity Reactions: REVLIMID is
contraindicated in patients who have demonstrated severe
hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic
epidermal necrolysis) to lenalidomide
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity: See Boxed WARNINGS
- Females of Reproductive Potential:
See Boxed WARNINGS
- Males: Lenalidomide is present in
the semen of patients receiving the drug. Males must always use a
latex or synthetic condom during any sexual contact with females of
reproductive potential while taking REVLIMID and for up to 4 weeks
after discontinuing REVLIMID, even if they have undergone a
successful vasectomy. Male patients taking REVLIMID must not donate
sperm
- Blood Donation: Patients must not
donate blood during treatment with REVLIMID and for 4 weeks
following discontinuation of the drug because the blood might be
given to a pregnant female patient whose fetus must not be exposed
to REVLIMID
REVLIMID REMS® Program: See Boxed WARNINGS: Prescribers
and pharmacies must be certified with the REVLIMID REMS program by
enrolling and complying with the REMS requirements; pharmacies must
only dispense to patients who are authorized to receive REVLIMID.
Patients must sign a Patient-Physician Agreement Form and comply
with REMS requirements; female patients of reproductive potential
who are not pregnant must comply with the pregnancy testing and
contraception requirements and males must comply with contraception
requirements
Hematologic Toxicity: REVLIMID can cause significant
neutropenia and thrombocytopenia. Monitor patients with neutropenia
for signs of infection. Advise patients to observe for bleeding or
bruising, especially with use of concomitant medications that may
increase risk of bleeding. MM:
Patients taking REVLIMID/dex or REVLIMID as maintenance therapy
should have their complete blood counts (CBC) assessed every 7 days
for the first 2 cycles, on days 1 and 15 of cycle 3, and every 28
days thereafter. MDS: 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
dose reduction. Please see the Black Box WARNINGS for
further information. MCL:
Patients taking REVLIMID for MCL should have their CBCs monitored
weekly for the first cycle (28 days), every 2 weeks during cycles
2-4, and then monthly thereafter. Patients may require dose
interruption and/or dose reduction
Venous and Arterial Thromboembolism: See Boxed WARNINGS:
Venous thromboembolic events (DVT and PE) and arterial thromboses
(MI and CVA) are increased in patients treated with REVLIMID.
Patients with known risk factors, including prior thrombosis, may
be at greater risk and actions should be taken to try to minimize
all modifiable factors (e.g., hyperlipidemia, hypertension,
smoking). Thromboprophylaxis is recommended and the regimen should
be based on patient’s underlying risks. ESAs and estrogens may
further increase the risk of thrombosis and their use should be
based on a benefit-risk decision
Increased Mortality in Patients with CLL: In a clinical
trial in the first-line treatment of patients with CLL, single
agent REVLIMID therapy increased the risk of death as compared to
single agent chlorambucil. Serious adverse cardiovascular
reactions, including atrial fibrillation, myocardial infarction,
and cardiac failure, occurred more frequently in the REVLIMID arm.
REVLIMID is not indicated and not recommended for use in CLL
outside of controlled clinical trials
Second Primary Malignancies (SPM): In clinical trials in
patients with MM receiving REVLIMID, an increase of hematologic
plus solid tumor SPM, notably AML and MDS, have been observed.
Monitor patients for the development of SPM. Take into account both
the potential benefit of REVLIMID and risk of SPM when considering
treatment
Increased Mortality with Pembrolizumab: In clinical
trials in patients with multiple myeloma, the addition of
pembrolizumab to a thalidomide analogue plus dexamethasone resulted
in increased mortality. Treatment of patients with multiple myeloma
with a PD-1 or PD-L1 blocking antibody in combination with a
thalidomide analogue plus dexamethasone is not recommended outside
of controlled clinical trials
Hepatotoxicity: Hepatic failure, including fatal cases,
has occurred in patients treated with REVLIMID/dex. Pre-existing
viral liver disease, elevated baseline liver enzymes, and
concomitant medications may be risk factors. Monitor liver enzymes
periodically. Stop REVLIMID upon elevation of liver enzymes. After
return to baseline values, treatment at a lower dose may be
considered
Severe Cutaneous Reactions: Severe cutaneous reactions
including Stevens-Johnson syndrome (SJS), toxic epidermal
necrolysis (TEN), and drug reaction with eosinophilia and systemic
symptoms (DRESS) have been reported. These events can be fatal.
Patients with a prior history of Grade 4 rash associated with
thalidomide treatment should not receive REVLIMID. Consider
REVLIMID interruption or discontinuation for Grade 2-3 skin rash.
Permanently discontinue REVLIMID for Grade 4 rash, exfoliative or
bullous rash, or for other severe cutaneous reactions such as SJS,
TEN, or DRESS.
Tumor Lysis Syndrome (TLS): Fatal instances of TLS have
been reported during treatment with lenalidomide. The patients at
risk of TLS are those with high tumor burden prior to treatment.
These patients should be monitored closely and appropriate
precautions taken
Tumor Flare Reaction (TFR): TFR has occurred during
investigational use of lenalidomide for CLL and lymphoma.
Monitoring and evaluation for TFR is recommended in patients with
MCL. Tumor flare may mimic the progression of disease (PD). In
patients with Grade 3 or 4 TFR, it is recommended to withhold
treatment with REVLIMID until TFR resolves to ≤Grade 1. REVLIMID
may be continued in patients with Grade 1 and 2 TFR without
interruption or modification, at the physician’s discretion
Impaired Stem Cell Mobilization: A decrease in the number
of CD34+ cells collected after treatment (>4 cycles) with
REVLIMID has been reported. Consider early referral to transplant
center to optimize timing of the stem cell collection
Thyroid Disorders: Both hypothyroidism and
hyperthyroidism have been reported. Measure thyroid function before
start of REVLIMID treatment and during therapy
Early Mortality in Patients with MCL: In another MCL
study, there was an increase in early deaths (within 20 weeks),
12.9% in the REVLIMID arm versus 7.1% in the control arm. Risk
factors for early deaths include high tumor burden, MIPI score at
diagnosis, and high WBC at baseline (≥10 x 109/L)
Hypersensitivity: Hypersensitivity, including angioedema,
anaphylaxis, and anaphylactic reactions to REVLIMID has been
reported. Permanently discontinue REVLIMID for angioedema and
anaphylaxis.
ADVERSE REACTIONS
Multiple Myeloma
- In newly diagnosed: The most frequently reported Grade 3
or 4 reactions included neutropenia, anemia, thrombocytopenia,
pneumonia, asthenia, fatigue, back pain, hypokalemia, rash,
cataract, lymphopenia, dyspnea, DVT, hyperglycemia, and leukopenia.
The highest frequency of infections occurred in Arm Rd Continuous
(75%) compared to Arm MPT (56%). There were more Grade 3 and 4 and
serious adverse reactions of infection in Arm Rd Continuous than
either Arm MPT or Rd18
- The most common adverse reactions reported in ≥20% (Arm Rd
Continuous): diarrhea (46%), anemia (44%), neutropenia (35%),
fatigue (33%), back pain (32%), asthenia (28%), insomnia (28%),
rash (26%), decreased appetite (23%), cough (23%), dyspnea (22%),
pyrexia (21%), abdominal pain (21%), muscle spasms (20%), and
thrombocytopenia (20%)
- Maintenance Therapy Post Auto-HSCT: The most frequently
reported Grade 3 or 4 reactions in ≥20% (REVLIMID arm) included
neutropenia, thrombocytopenia, and leukopenia. The serious adverse
reactions of lung infection and neutropenia (more than 4.5%)
occurred in the REVLIMID arm
- The most frequently reported adverse reactions in ≥20%
(REVLIMID arm) across both maintenance studies (Study 1, Study 2)
were neutropenia (79%, 61%), thrombocytopenia (72%, 24%),
leukopenia (23%, 32%), anemia (21%, 9%), upper respiratory tract
infection (27%, 11%), bronchitis (5%, 47%), nasopharyngitis (2%,
35%), cough (10%, 27%), gastroenteritis (0%, 23%), diarrhea (55%,
39%), rash (32%, 8%), fatigue (23%, 11%), asthenia (0%, 30%),
muscle spasm (0%, 33%), and pyrexia (8%, 21%)
- After at least one prior therapy: The most common
adverse reactions reported in ≥20% (REVLIMID/dex vs dex/placebo):
fatigue (44% vs 42%), neutropenia (42% vs 6%), constipation (41% vs
21%), diarrhea (39% vs 27%), muscle cramp (33% vs 21%), anemia (31%
vs 24%), pyrexia (28% vs 23%), peripheral edema (26% vs 21%),
nausea (26% vs 21%), back pain (26% vs 19%), upper respiratory
tract infection (25% vs 16%), dyspnea (24% vs 17%), dizziness (23%
vs 17%), thrombocytopenia (22% vs 11%), rash (21% vs 9%), tremor
(21% vs 7%), and weight decreased (20% vs 15%)
Myelodysplastic
Syndromes
- Grade 3 and 4 adverse events reported in ≥ 5% of patients with
del 5q MDS were neutropenia (53%), thrombocytopenia (50%),
pneumonia (7%), rash (7%), anemia (6%), leukopenia (5%), fatigue
(5%), dyspnea (5%), and back pain (5%)
- Adverse events reported in ≥15% of del 5q MDS patients
(REVLIMID): thrombocytopenia (61.5%), neutropenia (58.8%), diarrhea
(49%), pruritus (42%), rash (36%), fatigue (31%), constipation
(24%), nausea (24%), nasopharyngitis (23%), arthralgia (22%),
pyrexia (21%), back pain (21%), peripheral edema (20%), cough
(20%), dizziness (20%), headache (20%), muscle cramp (18%), dyspnea
(17%), pharyngitis (16%), epistaxis (15%), asthenia (15%), upper
respiratory tract infection (15%)
Mantle Cell Lymphoma
- Grade 3 and 4 adverse events reported in ≥5% of patients
treated with REVLIMID in the MCL trial (N=134) included neutropenia
(43%), thrombocytopenia (28%), anemia (11%), pneumonia (9%),
leukopenia (7%), fatigue (7%), diarrhea (6%), dyspnea (6%), and
febrile neutropenia (6%)
- Adverse events reported in ≥15% of patients treated with
REVLIMID in the MCL trial included neutropenia (49%),
thrombocytopenia (36%), fatigue (34%), anemia (31%), diarrhea
(31%), nausea (30%), cough (28%), pyrexia (23%), rash (22%),
dyspnea (18%), pruritus (17%), peripheral edema (16%), constipation
(16%), and leukopenia (15%)
DRUG INTERACTIONS
Periodic monitoring of digoxin plasma levels is recommended due
to increased Cmax and AUC with concomitant REVLIMID therapy.
Patients taking concomitant therapies such as erythropoietin
stimulating agents or estrogen containing therapies may have an
increased risk of thrombosis. It is not known whether there is an
interaction between dex and warfarin. Close monitoring of PT and
INR is recommended in patients with MM taking concomitant
warfarin
USE IN SPECIFIC POPULATIONS
- PREGNANCY: See Boxed WARNINGS: If pregnancy does occur
during treatment, immediately discontinue the drug and refer
patient to an obstetrician/gynecologist experienced in reproductive
toxicity for further evaluation and counseling. There is a REVLIMID
pregnancy exposure registry that monitors pregnancy outcomes in
females exposed to REVLIMID during pregnancy as well as female
partners of male patients who are exposed to REVLIMID. This
registry is also used to understand the root cause for the
pregnancy. Report any suspected fetal exposure to REVLIMID to the
FDA via the MedWatch program at 1-800-FDA-1088 and also to Celgene
Corporation at 1-888-423-5436
- LACTATION: There is no information regarding the
presence of lenalidomide in human milk, the effects of REVLIMID on
the breastfed infant, or the effects of REVLIMID on milk
production. Because many drugs are excreted in human milk and
because of the potential for adverse reactions in breastfed infants
from REVLIMID, advise female patients not to breastfeed during
treatment with REVLIMID
- PEDIATRIC USE: Safety and effectiveness have not been
established in pediatric patients
- RENAL IMPAIRMENT: Adjust the starting dose of REVLIMID
based on the creatinine clearance value and in patients on
dialysis
Please see full Prescribing Information, including Boxed
WARNINGS.
Please see full SmPC for further information.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in
the discovery, development and commercialization of innovative
therapies for the treatment of cancer and inflammatory diseases
through next-generation solutions in protein homeostasis,
immuno-oncology, epigenetics, immunology and neuro-inflammation.
For more information, please visit www.celgene.com. Follow Celgene
on Social Media: @Celgene, Pinterest,
LinkedIn, Facebook 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. Celgene undertakes 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 each company's
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 the Annual Report on Form 10-K and other reports of each
company filed with the Securities and Exchange Commission,
including factors related to the proposed transaction between
Bristol-Myers Squibb and Celgene, such as, but not limited to, the
risks that: management’s time and attention is diverted on
transaction related issues; disruption from the transaction make it
more difficult to maintain business, contractual and operational
relationships; legal proceedings are instituted against
Bristol-Myers Squibb, Celgene or the combined company could delay
or prevent the proposed transaction; and Bristol-Myers Squibb,
Celgene or the combined company is unable to retain key
personnel.
1 Scott DW, Gascoyne RD. The tumour microenvironment in B cell
lymphomas. Nat Rev Cancer. 2014;14(8):517-534. 2 Kridel R, Sehn LH,
Gascoyne RD. Pathogenesis of follicular lymphoma. J Clin Invest.
2012;122(10):3424-3431. 3 Chiu H, Trisal P, Bjorklund C, et al.
Combination lenalidomide-rituximab immunotherapy activates
anti-tumour immunity and induces tumour cell death by complementary
mechanisms of action in follicular lymphoma. Br J Haematol.
2019;185(2):240-253. 4 European Cancer Information System.
Estimates of cancer incidence and mortality in 2018, for all
countries. Available at:
https://ecis.jrc.ec.europa.eu/explorer.php. Accessed August 2019. 5 European Society for
Medical Oncology. Follicular Lymphoma: A Guide for Patients. 2014.
Available at:
https://www.esmo.org/content/download/52236/963497/file/EN-Follicular-Lymphoma-Guide-for-Patients.pdf
. Accessed September 2019. 6 Leonard JP, Trneny M, Izutsu K, et al.
AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus
Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma.
J Clin Oncol. 2019;10;37(14):1188-1199. 7 ClinicalTrials.gov
Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory
Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal
Zone Lymphoma) (AUGMENT). Available at:
https://clinicaltrials.gov/ct2/show/NCT01938001 Accessed September
2019. 8 ClinicalTrials.gov Lenalidomide Plus Rituximab Followed by
Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory
Follicular, Marginal Zone or Mantle Cell Lymphoma (MAGNIFY).
Available at: https://clinicaltrials.gov/ct2/show/NCT01996865
Accessed August 2019. 9 American Cancer Society. Lymphoma.
Available at: https://www.cancer.org/cancer/lymphoma.html. Accessed
August 2019. 10 American Cancer Society. What is Hodgkin Lymphoma?
Available at:
https://www.cancer.org/cancer/hodgkin-lymphoma/about/what-is-hodgkin-disease.html.
Accessed August 2019. 11 American Cancer Society. What is
Non-Hodgkin Lymphoma? Available at:
https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/what-is-non-hodgkin-lymphoma.html.
Accessed August 2019. 12 Lymphoma Action. Follicular lymphoma.
Available at:
https://lymphoma-action.org.uk/types-lymphoma-non-hodgkin-lymphoma/follicular-lymphoma.
Accessed November 2019. 13 Montoto S, Lopez-Guillermo A, Ferrer A,
et al. Survival after progression in patients with follicular
lymphoma: analysis of prognostic factors. Ann Oncol.
2002;13(4):523-30.
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