WOODCLIFF LAKE, N.J., Oct. 8, 2015 /PRNewswire/ -- Eisai Inc. announced the decision of the National Comprehensive Cancer Network® (NCCN®)
to recommend LENVIMA™ (lenvatinib) as the preferred agent for the
treatment of patients with progressive and/or symptomatic metastatic
differentiated thyroid cancer, including papillary, follicular and
Hürthle cell thyroid carcinoma, that no longer responds to radioactive
iodine therapy in the 2015 NCCN Clinical Practice Guidelines in Oncology
(NCCN Guidelines®) for Thyroid Carcinoma. The panel based
its recommendation on the response rate seen in the pivotal Phase 3
SELECT clinical trial.
LENVIMA, a receptor tyrosine
kinase inhibitor discovered and developed by Eisai, was approved by the
U.S. Food and Drug Administration in February 2015
for the treatment of locally recurrent or metastatic, progressive,
radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC).
The most common types of thyroid
cancer, papillary and follicular (including Hürthle cell), are
classified as differentiated thyroid cancer (DTC) and account for
approximately 95% of all cases. While most DTC patients are curable with
surgery and radioactive iodine treatment, the prognosis for those
patients whose cancers persist or recur is poor. There are a limited
number of treatment options for this radioactive iodine-refractory form
of thyroid cancer.
"We are pleased that the NCCN has
recommended the use of LENVIMA as the preferred treatment option for
patients with progressive and/or symptomatic metastatic differentiated
thyroid cancer who have become refractory to radioactive iodine
therapy," said RuiRong Yuan,
MD, Chief Medical Officer, Eisai Global Oncology Business Unit, and
Vice President, Medical Affairs, Americas Region, Eisai Inc. "This
decision underscores the role of LENVIMA and provides oncologists and
endocrinologists with an evidence-based, consensus-driven guide for
decision-making when treating patients with this rare and
difficult-to-treat cancer."
The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)
document provides evidence-based, consensus-driven management to help
patients receive preventive, diagnostic, treatment, and supportive
services that are most likely to lead to optimal outcomes. The intent of
the NCCN Guidelines is to assist in the decision-making process of
individuals involved in cancer care—including physicians, nurses,
pharmacists, payers, patients and their families—with the ultimate goal
of advancing patient care in the fight against cancer.
About LENVIMA™ (lenvatinib)
LENVIMA™ (lenvatinib) is indicated
for the treatment of patients with locally recurrent or metastatic,
progressive, radioactive iodine-refractory differentiated thyroid cancer
(DTC).
LENVIMA, discovered and developed
by Eisai, is a receptor tyrosine kinase (RTK) inhibitor that inhibits
the kinase activities of vascular endothelial growth factor (VEGF)
receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA also
inhibits other RTKs that have been implicated in pathogenic
angiogenesis, tumor growth, and cancer progression in addition to their
normal cellular functions, including fibroblast growth factor (FGF)
receptors FGFR1, 2, 3, and 4; the platelet derived growth factor
receptor alpha (PDGFRα), KIT, and RET. LENVIMA™ (lenvatinib) was
approved under Priority Review designation for locally recurrent or
metastatic, progressive, radioactive iodine-refractory differentiated
thyroid cancer by the FDA in February 2015. Eisai was granted Orphan Drug Designation (ODD) for lenvatinib in various types of thyroid cancer in the United States, Japan, and Europe.
Important Safety Information
Warnings and Precautions
- Hypertension reported in 73% of patients on LENVIMA vs 16% for placebo (44% vs 4% ≥grade 3). Blood pressure should be controlled prior to treatment. Withhold dose for grade 3 hypertension despite optimal antihypertensive therapy; resume at reduced dose when controlled at ≤grade 2. Discontinue for life-threatening hypertension.
- Cardiac dysfunction reported in 7% of patients on LENVIMA vs 2% for placebo (2% vs 0% ≥grade 3). Monitor for signs/symptoms of cardiac decompensation. Withhold for grade 3 cardiac dysfunction. Resume at reduced dose or discontinue based on severity and persistence of cardiac dysfunction. Discontinue for grade 4 cardiac dysfunction.
- Arterial thromboembolic events reported in 5% of patients on LENVIMA vs 2% for placebo (3% vs 1% ≥grade 3). Discontinue following an arterial thrombotic event. The safety of resuming LENVIMA after an arterial thromboembolic event has not been established, and LENVIMA has not been studied in patients who have had an arterial thromboembolic event within the previous 6 months.
- ALT and AST increases (≥grade 3) occurred in 4% and 5% of patients on LENVIMA vs 0% for placebo. Across clinical studies in which 1108 patients received LENVIMA, hepatic failure (including fatal events) was reported in 3 patients and acute hepatitis in 1 patient. Monitor liver function before initiation, then every 2 weeks for first 2 months, and at least monthly thereafter during treatment. Withhold dose for liver impairment ≥grade 3. Resume at reduced dose or discontinue based on severity/persistence of hepatotoxicity. Discontinue for hepatic failure.
- Proteinuria reported in 34% of patients on LENVIMA vs 3% for placebo (11% vs 0% ≥grade 3). Monitor for proteinuria before and during treatment. Withhold dose for ≥2 grams of proteinuria/24 hours. Resume at reduced dose when proteinuria is <2 discontinue="" for="" gm="" hours.="" li="" nephrotic="" syndrome.="">
- Events of renal impairment reported in 14% of patients on LENVIMA vs 2% for placebo (3% vs 1% ≥grade 3). Withhold LENVIMA for grade 3 or 4 renal failure/impairment. Resume at reduced dose or discontinue, depending on severity/persistence of renal impairment.
- Events of gastrointestinal (GI) perforation or fistula reported in 2% of patients on LENVIMA vs 0.8% for placebo. Discontinue in patients who develop GI perforation or life-threatening fistula.
- QT/QTc interval prolongation reported in 9% of patients on LENVIMA vs 2% for placebo (2% vs 0% ≥grade 3). Monitor ECG in patients with congenital long QT syndrome, CHF, bradyarrhythmias, or patients taking drugs known to prolong the QT interval. Monitor and correct electrolyte abnormalities in all patients. Withhold dose for ≥grade 3 QT interval prolongation. Resume at reduced dose when QT prolongation resolves to grade 0, 1, or baseline.
- Hypocalcemia ≥grade 3 reported in 9% of patients on LENVIMA (2% for placebo). Monitor blood calcium levels at least monthly and replace calcium as necessary. Interrupt and adjust LENVIMA as necessary. In most cases, hypocalcemia responded to replacement and dose interruption/reduction.
- Across clinical studies in which 1108 patients received LENVIMA, reversible posterior leukoencephalopathy syndrome (RPLS) was reported in 3 patients. Withhold LENVIMA for RPLS until fully resolved. Resume at reduced dose or discontinue based on the severity and persistence of neurologic symptoms.
- Hemorrhagic events occurred in 35% of patients on LENVIMA vs 18% for placebo (2% vs 3% ≥grade 3). The most frequently reported hemorrhagic event was epistaxis (11% grade 1 and 1% grade 2). Discontinuation due to hemorrhagic events occurred in 1% of patients on LENVIMA. There was 1 fatal intracranial hemorrhage case among 16 patients who received LENVIMA and had CNS metastases at baseline. Withhold dose for grade 3 hemorrhage. Resume at reduced dose or discontinue, based on severity/persistence of hemorrhage. Discontinue for grade 4 hemorrhage.
- LENVIMA™ (lenvatinib) impairs exogenous thyroid suppression. In patients with a normal baseline TSH, elevation of TSH level above 0.5 mU/L was observed post baseline in 57% of patients on LENVIMA (14% for placebo). Monitor TSH levels monthly and adjust thyroid replacement medication as needed in patients with DTC.
- LENVIMA may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with LENVIMA and for at least 2 weeks following completion of therapy.
Adverse Reactions
- The most common adverse reactions observed in LENVIMA-treated patients vs placebo-treated patients were hypertension (73% vs 16%), fatigue (67% vs 35%), diarrhea (67% vs 17%), arthralgia/myalgia (62% vs 28%), decreased appetite (54% vs 18%), weight decreased (51% vs 15%), nausea (47% vs 25%), stomatitis (41% vs 8%), headache (38% vs 11%), vomiting (36% vs 15%), proteinuria (34% vs 3%), palmar-plantar erythrodysesthesia syndrome (32% vs 1%), abdominal pain (31% vs 11%), and dysphonia (31% vs 5%).
Use in Specific Populations
- Because of the potential for serious adverse reactions in nursing infants, advise women to discontinue breastfeeding during treatment.
- LENVIMA may result in reduced fertility in females of reproductive potential, and may result in damage to male reproductive tissues, leading to reduced fertility of unknown duration.
For more information about LENVIMA, click here for the full Prescribing Information or visit www.LENVIMA.com.
About Eisai Inc.At Eisai Inc., human health care is
our goal. We give our first thoughts to patients and their families,
and helping to increase the benefits health care provides. As the U.S.
pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a
passionate commitment to patient care that is the driving force behind
our efforts to help address unmet medical needs. We are a fully
integrated pharmaceutical business with discovery, clinical,
manufacturing and marketing capabilities. Our key areas of commercial
focus include oncology and specialty care (Alzheimer's disease, epilepsy
and metabolic disorders). To learn more about Eisai Inc., please visit
us at www.eisai.com/US.
Eisai Inc. has affiliates that are
part of a global product creation organization that includes R&D
facilities in Massachusetts, New Jersey and Pennsylvania, as well as a
global demand chain organization that includes facilities in
Maryland and North Carolina. Eisai's global areas of R&D focus
include neuroscience; oncology; metabolic disorders; vascular,
inflammatory and immunological reaction; and antibody-based programs.
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