Approval marks the first chemotherapy-free
combination regimen for patients who have relapsed or did not
respond to previous treatment
Approval based on Phase 3 AUGMENT study, which
showed the combination significantly improved median
progression-free survival versus rituximab monotherapy
Celgene Corporation (NASDAQ: CELG) today announced the U.S. Food
and Drug Administration (FDA) approved REVLIMID® (lenalidomide) in
combination with a rituximab product (R²) for the treatment of
adult patients with previously treated follicular lymphoma (FL) or
marginal zone lymphoma (MZL) following Priority Review designation.
This is the first FDA-approved combination treatment regimen for
patients with these indolent forms of non-Hodgkin’s lymphoma (NHL)
that does not include chemotherapy.
“Nearly 15 years following the initial FDA approval, REVLIMID
continues to demonstrate benefits for new patient populations,”
said Jay Backstrom, M.D., M.P.H., Chief Medical Officer for
Celgene. “REVLIMID in combination with rituximab (R2) leads to
immune-mediated treatment effects and represents a
chemotherapy-free treatment option that can help patients with
previously treated follicular lymphoma and marginal zone lymphoma
delay disease progression.”
Immune dysfunction (meaning the immune system is not functioning
optimally) is a defining aspect of indolent forms of NHL, including
FL and MZL.1,2 When this dysfunction occurs, lymphocytes in the
immune system either fail to detect or target cancerous
cells.1,2
“Chemotherapy continues to be a standard of care for indolent
forms of NHL, but most patients will relapse or become refractory
to their current treatment,” said Meghan Gutierrez, Chief Executive
Officer for the Lymphoma Research Foundation. “This approval
represents a new therapeutic option for previously treated patients
with follicular and marginal zone lymphomas, including those who
relapse or no longer respond to initial treatment. We commend the
patients and scientists who participated in the clinical study for
advancing lymphoma research and treatment.”
The approval of R2 is based primarily on results from the
randomized, 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) and MZL
(n=63).
In the AUGMENT study, treatment with R2 demonstrated a
statistically significant improvement in the primary endpoint of
progression-free survival (PFS), evaluated by an independent review
committee, versus rituximab-placebo. The median PFS was 39.4 months
for patients treated with R2 and 14.1 months for those treated with
rituximab-placebo (HR: 0.46; 95% CI, 0.34-0.62; P<0.0001).
Median follow-up time was 28.3 months (range, 0.1-51.3) in the
intent to treat population (n=358). Although not statistically
powered to detect a difference in overall survival, a numeric trend
for improvement in overall survival (a secondary endpoint) was also
seen with R2 versus rituximab-placebo (16 vs. 26 deaths) (HR: 0.61;
95% CI, 0.33-1.13).
REVLIMID is only available through a restricted distribution
program called REVLIMID REMS® program. REVLIMID has a boxed warning
for embryo-fetal toxicity, hematologic toxicity, and venous and
arterial thromboembolism. Adverse reactions reported in ≥15% of
patients with FL/MZL treated with R2 were: neutropenia (58%),
diarrhea (31%), constipation (26%), cough (24%), fatigue (22%),
rash (22%), pyrexia (21%), leukopenia (20%), pruritus (20%), upper
respiratory tract infections (18%), abdominal pain (18%), anemia
(16%), headache (15%), thrombocytopenia (15%).
A Marketing Authorization Application for R2 is currently under
review by the European Medicines Agency for the treatment of
relapsed/refractory FL and MZL. A supplemental new drug application
was also submitted to the Japanese Pharmaceuticals and Medical
Devices Agency for an additional indication as well as dosage and
administration updates for lenalidomide in combination with
rituximab for the treatment of relapsed/refractory indolent B-cell
NHL.
About Indolent 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.3 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.3,4,5
Indolent lymphomas are slow-growing forms of the disease, which
can often be asymptomatic or have fewer symptoms upon diagnosis.6
Indolent lymphomas account for approximately 40% of all NHL cases.6
In patients with relapsed/refractory lymphoma, the disease has
either responded to treatment but then returned or has not
responded to initial treatment.7
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 and marginal
zone lymphoma. AUGMENT included patients diagnosed with Grade 1, 2
or 3a follicular lymphoma, who received at least 1 prior systemic
therapy, were refractory or relapsed, not rituximab-refractory.
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.
About REVLIMID®
REVLIMID® (lenalidomide) in combination with
dexamethasone (dex) is indicated for the treatment of adult
patients with multiple myeloma (MM)
REVLIMID is indicated as maintenance therapy in adult
patients with MM following autologous hematopoietic stem cell
transplantation (auto-HSCT)
REVLIMID is indicated for the treatment of adult patients
with transfusion-dependent anemia due to low-or intermediate-1–risk
myelodysplastic syndromes (MDS) associated with a deletion 5q
cytogenetic abnormality with or without additional cytogenetic
abnormalities
REVLIMID is indicated for the treatment of adult patients
with mantle cell lymphoma (MCL) whose disease has relapsed or
progressed after two prior therapies, one of which included
bortezomib
REVLIMID in combination with a rituximab product is indicated
for the treatment of adult patients with previously treated
follicular lymphoma (FL)
REVLIMID in combination with a rituximab product is indicated
for the treatment of adult patients with previously treated
marginal zone lymphoma (MZL)
REVLIMID is not indicated and is not recommended for the
treatment of patients with chronic lymphocytic leukemia (CLL)
outside of controlled clinical trials
REVLIMID is only available through a restricted distribution
program, REVLIMID REMS®.
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. Patients may require dose interruption
and/or dose reduction. MM: Monitor complete blood counts
(CBC) in patients taking REVLIMID + dexamethasone or REVLIMID as
maintenance therapy, every 7 days for the first 2 cycles, on days 1
and 15 of cycle 3, and every 28 days thereafter. MDS: Monitor CBC in patients on
therapy for del 5q MDS, weekly for the first 8 weeks of therapy and
at least monthly thereafter. See Boxed WARNINGS for further
information. MCL:
Monitor CBC in patients taking REVLIMID for MCL weekly for the
first cycle (28 days), every 2 weeks during cycles 2-4, and then
monthly thereafter. FL/MZL: Monitor CBC in patients
taking REVLIMID for FL or MZL weekly for the first 3 weeks of Cycle
1 (28 days), every 2 weeks during Cycles 2-4, and then monthly
thereafter
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 the 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 and in patients with FL or
MZLreceiving REVLIMID + rituximab therapy, an increase of
hematologic plus solid tumor SPM, notably AML, have been observed.
In MM patients, MDS was also 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 MM, the addition of pembrolizumab to a
thalidomide analogue plus dexamethasone resulted in increased
mortality. Treatment of patients with MM 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 + dexamethasone.
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 Including Hypersensitivity
Reactions: Angioedema and 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. REVLIMID interruption or
discontinuation should be considered for
Grade 2-3 skin rash. REVLIMID must be discontinued for
angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS,
TEN, or DRESS is suspected and should not be resumed following
discontinuation for these reactions
Tumor Lysis Syndrome (TLS): Fatal instances of TLS have
been reported during treatment with REVLIMID. The patients at risk
of TLS are those with high tumor burden prior to treatment. Closely
monitor patients at risk and take appropriate preventive
approaches
Tumor Flare Reaction (TFR): TFR has occurred during
investigational use of REVLIMID for CLL and lymphoma. Monitoring
and evaluation for TFR is recommended in patients with MCL, FL, or
MZL.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
starting 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)
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%)
Follicular Lymphoma/Marginal Zone
Lymphoma
- Fatal adverse reactions occurred in 6
patients (1.5%) receiving REVLIMID + rituximab across both trials.
Fatal adverse reactions (1 each) included: cardio-respiratory
arrest, arrhythmia, cardiopulmonary failure, multiple organ
dysfunction syndrome, sepsis, and acute kidney injury. The most
frequent serious adverse reaction that occurred in the
REVLIMID/rituximab arm was
febrile neutropenia (3.0%).
- Grade 3 and 4 adverse reactions
reported in ≥5% of patients treated in the FL/MZL trial with
REVLIMID + rituximab were: neutropenia (50%) and leukopenia
(7%)
- Adverse reactions reported in ≥15% of
patients with FL/MZL treated with REVLIMID + rituximab were:
neutropenia (58%), diarrhea (31%), constipation (26%), cough (24%),
fatigue (22%), rash (22%), pyrexia (21%), leukopenia (20%),
pruritus (20%), upper respiratory tract infections (18%), abdominal
pain (18%), anemia (16%), headache (15%), thrombocytopenia
(15%)
DRUG INTERACTIONS
Periodically monitor digoxin plasma levels 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
dexamethasone 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
- 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, for REVLIMID.
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,
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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 American Cancer Society. Lymphoma.
Available at: https://www.cancer.org/cancer/lymphoma.html. Accessed
April 2019.4 American Cancer Society. What is Hodgkin Lymphoma?
Available at:
https://www.cancer.org/cancer/hodgkin-lymphoma/about/what-is-hodgkin-disease.html.
Accessed April 2019.5 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 April 2019.6 Leukemia & Lymphoma Society. NHL
Subtypes. Available at:
https://www.lls.org/lymphoma/non-hodgkin-lymphoma/diagnosis/nhl-subtypes.
Accessed April 2019.7 Leukemia & Lymphoma Society. Relapsed and
Refractory. Available at:
https://www.lls.org/lymphoma/non-hodgkin-lymphoma/treatment/refractory-and-relapsed.
Accessed April 2019.
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