THOUSAND OAKS, Calif.,
Dec. 17, 2020 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced that the U.S. Food and Drug
Administration (FDA) has approved RIABNI™ (rituximab-arrx), a
biosimilar to Rituxan® (rituximab), for the treatment of
adult patients with Non-Hodgkin's Lymphoma (NHL), Chronic
Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA)
(Wegener's Granulomatosis), and Microscopic Polyangiitis (MPA).
RIABNI will be made available in the U.S. in January 2021.
"The approval of RIABNI represents an important milestone
across our biosimilar and oncology portfolios," said Murdo Gordon, executive vice president of Global
Commercial Operations at Amgen. "Following the proven success of
KANJINTI® (trastuzumab-anns) and MVASI®
(bevacizumab-awwb) in the U.S. marketplace, RIABNI reaffirms
Amgen's long-term commitment to providing high quality biosimilars
that can potentially offer more affordable, effective
treatment options for cancer and other serious diseases and
that contribute to the sustainability of healthcare systems."
RIABNI, a CD20-directed cytolytic antibody, was proven to
be highly similar to Rituxan based on a totality of evidence, which
included comparative analytical, nonclinical and clinical data,
with no clinically meaningful differences in safety or
effectiveness. The data package was composed of, in part, results
from a pharmacokinetic (PK) similarity study and a comparative
clinical study.
The randomized, double-blind, comparative clinical study
evaluated the efficacy, pharmacokinetics (PK), pharmacodynamics
(PD), safety, tolerability and immunogenicity of RIABNI compared to
Rituxan in subjects with grade 1, 2, or 3a follicular B-cell NHL
and low tumor burden. There were 256 patients enrolled and
randomized (1:1) to receive 375 mg/m2 intravenous
infusion of either RIABNI or Rituxan, once weekly for 4 weeks
followed by dosing at weeks 12 and 20. The primary endpoint, an
assessment of overall response rate (ORR) by week 28, was within
the prespecified margin for RIABNI compared to Rituxan, showing
clinical equivalence. PK, PD, safety and immunogenicity of RIABNI
were similar to Rituxan.
The Wholesale Acquisition Cost (WAC or "list price") of RIABNI
in the U.S. will be 23.7% lower than the reference product,
Rituxan. RIABNI is being made available at a WAC of
$716.80 per 100 mg and $3,584.00 per 500 mg single-dose vial, 23.7% less
than the WAC for Rituxan, 15.2% less than the WAC for
Truxima® (biosimilar to Rituxan) and matching the WAC
for Ruxience® (biosimilar to Rituxan). At launch,
RIABNI will be priced 16.7% below the current Rituxan Average
Selling Price (ASP). RIABNI will be available from both wholesalers
and specialty distributors.
Amgen has a total of 10 biosimilars in its portfolio, five of
which have been approved in the U.S., and three that are approved
in the European Union (EU).
About RIABNI™ (rituximab-arrx) in
the U.S.
RIABNI is a biosimilar to Rituxan, an anti-CD20
monoclonal antibody. The active ingredient of RIABNI is a
monoclonal antibody that has the same amino acid sequence as
Rituxan. RIABNI also has the same strength as Rituxan, and the
dosage form and route of administration are identical to the IV
formulation of Rituxan.
RIABNI is currently not yet available commercially. This is
not an offer for sale. The following information is derived
from the approved label in the U.S.
In the U.S., RIABNI is approved for:
Non-Hodgkin's Lymphoma (NHL)
RIABNI (rituximab-arrx)
is indicated for the treatment of adult patients with:
- Relapsed or refractory, low-grade or follicular, CD20-positive,
B-cell NHL as a single agent.
- Previously untreated follicular, CD20-positive, B-cell NHL in
combination with first line chemotherapy and, in patients achieving
a complete or partial response to a rituximab product in
combination with chemotherapy, as single-agent maintenance
therapy.
- Non-progressing (including stable disease), low-grade,
CD20-positive, B-cell NHL as a single agent after first line
cyclophosphamide, vincristine, and prednisone (CVP)
chemotherapy.
- Previously untreated diffuse large B-cell, CD20-positive NHL in
combination with cyclophosphamide, doxorubicin, vincristine,
prednisone (CHOP) or other anthracycline-based chemotherapy
regimens.
Chronic Lymphocytic Leukemia (CLL)
RIABNI, in
combination with fludarabine and cyclophosphamide (FC), is
indicated for the treatment of adult patients with previously
untreated and previously treated CD20-positive CLL.
Granulomatosis with Polyangiitis (GPA) (Wegener's
Granulomatosis) and Microscopic
Polyangiitis (MPA)
RIABNI, in combination with
glucocorticoids, is indicated for the treatment of adult patients
with Granulomatosis with Polyangiitis (GPA) (Wegener's
Granulomatosis) and Microscopic Polyangiitis (MPA).
Important Safety Information
BOXED WARNINGS: FATAL INFUSION-RELATED REACTIONS,
SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION,
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
- Infusion-Related Reactions: Rituximab product administration
can result in serious, including fatal, infusion-related reactions.
Deaths within 24 hours of rituximab infusion have occurred.
Approximately 80% of fatal infusion-related reactions occurred in
association with the first infusion. Monitor patients closely.
Discontinue RIABNITM infusion for severe reactions and
provide medical treatment for Grade 3 or 4 infusion-related
reactions.
- Severe Mucocutaneous Reactions: Severe, including fatal,
mucocutaneous reactions can occur in patients receiving rituximab
products. Discontinue RIABNITM in patients who
experience a severe mucocutaneous reaction. The safety of
readministration of RIABNITM to patients with severe
mucocutaneous reactions has not been determined.
- Hepatitis B Virus (HBV) Reactivation: HBV reactivation can
occur in patients treated with rituximab products, in some cases
resulting in fulminant hepatitis, hepatic failure, and death.
Screen all patients for HBV infection before treatment initiation,
and monitor patients during and after treatment with
RIABNITM. Discontinue RIABNITM and
concomitant medications in the event of HBV reactivation.
- Progressive Multifocal Leukoencephalopathy (PML), including
fatal PML, can occur in patients receiving rituximab products.
Discontinue RIABNITM and consider discontinuation or
reduction of any concomitant chemotherapy or immunosuppressive
therapy in patients who develop PML.
Infusion-Related reactions (IRR)
- Rituximab products can cause severe, including fatal,
infusion-related reactions. Severe reactions typically occurred
during the first infusion with time to onset of 30-120
minutes.
- Rituximab-product-induced infusion-related reactions and
sequelae include urticaria, hypotension, angioedema, hypoxia,
bronchospasm, pulmonary infiltrates, acute respiratory distress
syndrome, myocardial infarction, ventricular fibrillation,
cardiogenic shock, anaphylactoid events, or death.
- Premedicate patients with an antihistamine and acetaminophen
prior to dosing. For patients with Granulomatosis with Polyangiitis
(GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis
(MPA), methylprednisolone 100 mg intravenously or its equivalent is
recommended 30 minutes prior to each infusion. Institute medical
management (e.g., glucocorticoids, epinephrine, bronchodilators, or
oxygen) for infusion-related reactions as needed. Depending on the
severity of the infusion-related reaction and the required
interventions, temporarily or permanently discontinue
RIABNITM. Resume infusion at a minimum 50% reduction in
rate after symptoms have resolved.
- Closely monitor the following patients: those with preexisting
cardiac or pulmonary conditions, those who experienced prior
cardiopulmonary adverse reactions, and those with high numbers of
circulating malignant cells (≥25,000/mm3).
Severe Mucocutaneous Reactions
- Mucocutaneous reactions, some with fatal outcome, can occur in
patients treated with rituximab products. These reactions include
paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid
dermatitis, vesiculobullous dermatitis, and toxic epidermal
necrolysis.
- The onset of these reactions has been variable and includes
reports with onset on the first day of rituximab exposure.
Discontinue RIABNITM in patients who experience a severe
mucocutaneous reaction. The safety of re-administration of
rituximab products to patients with severe mucocutaneous reactions
has not been determined.
Hepatitis B Virus Reactivation
- Hepatitis B virus (HBV) reactivation, in some cases resulting
in fulminant hepatitis, hepatic failure, and death, can occur in
patients treated with drugs classified as CD20-directed cytolytic
antibodies, including rituximab products. Cases have been reported
in patients who are hepatitis B surface antigen (HBsAg) positive
and also in patients who are HBsAg negative but are hepatitis B
core antibody (anti-HBc) positive. Reactivation also has occurred
in patients who appear to have resolved hepatitis B infection
(i.e., HBsAg negative, anti-HBc positive, and hepatitis B surface
antibody [anti-HBs] positive).
- HBV reactivation is defined as an abrupt increase in HBV
replication manifesting as a rapid increase in serum HBV DNA level
or detection of HBsAg in a person who was previously HBsAg negative
and anti-HBc positive. Reactivation of HBV replication is often
followed by hepatitis, i.e., increase in transaminase levels. In
severe cases, increase in bilirubin levels, liver failure, and
death can occur.
- Screen all patients for HBV infection by measuring HBsAg and
anti-HBc before initiating treatment with RIABNITM. For
patients who show evidence of prior hepatitis B infection (HBsAg
positive [regardless of antibody status] or HBsAg negative but
anti-HBc positive), consult with physicians with expertise in
managing hepatitis B regarding monitoring and consideration for HBV
antiviral therapy before and/or during RIABNITM
treatment.
- Monitor patients with evidence of current or prior HBV
infection for clinical and laboratory signs of hepatitis or HBV
reactivation during and for several months following
RIABNITM therapy. HBV reactivation has been reported up
to 24 months following completion of rituximab therapy.
- In patients who develop reactivation of HBV while on
RIABNITM, immediately discontinue RIABNITM
and any concomitant chemotherapy, and institute appropriate
treatment. Insufficient data exist regarding the safety of resuming
rituximab product treatment in patients who develop HBV
reactivation. Resumption of RIABNITM treatment in
patients whose HBV reactivation resolves should be discussed with
physicians with expertise in managing HBV.
Progressive Multifocal Leukoencephalopathy (PML)
- JC virus infection resulting in multifocal leukoencephalopathy
(PML) and death can occur in rituximab-product -treated patients
with hematologic malignancies or with autoimmune diseases. The
majority of patients with hematologic malignancies diagnosed with
PML received rituximab in combination with chemotherapy or as part
of a hematopoietic stem cell transplant. The patients with
autoimmune diseases had prior or concurrent immunosuppressive
therapy. Most cases of PML were diagnosed within 12 months of their
last infusion of rituximab.
- Consider the diagnosis of PML in any patient presenting with
new-onset neurologic manifestations. Evaluation of PML includes,
but is not limited to, consultation with a neurologist, brain MRI,
and lumbar puncture. Discontinue RIABNITM and consider
discontinuation or reduction of any concomitant chemotherapy or
immunosuppressive therapy in patients who develop PML.
Tumor Lysis Syndrome
- Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia,
or hyperphosphatemia from tumor lysis, some fatal, can occur within
12−24 hours after the first infusion of RIABNITM in
patients with non-Hodgkin's lymphoma (NHL). A high number of
circulating malignant cells (≥25,000/mm3), or high tumor
burden, confers a greater risk of TLS.
- Administer aggressive intravenous hydration and
anti-hyperuricemic therapy in patients at high risk for TLS.
Correct electrolyte abnormalities, monitor renal function and fluid
balance, and administer supportive care, including dialysis as
indicated.
Infections
- Serious, including fatal, bacterial, fungal, and new or
reactivated viral infections can occur during and following the
completion of rituximab product-based therapy. Infections have been
reported in some patients with prolonged hypogammaglobulinemia
(defined as hypogammaglobulinemia >11 months after rituximab
exposure).
- New or reactivated viral infections included cytomegalovirus,
herpes simplex virus, parvovirus B19, varicella zoster virus, West
Nile virus, and hepatitis B and C. Discontinue RIABNITM
for serious infections and institute appropriate anti-infective
therapy.
- RIABNITM is not recommended for use in patients with
severe, active infections.
Cardiovascular Adverse Reactions
- Cardiac adverse reactions, including ventricular fibrillation,
myocardial infarction, and cardiogenic shock may occur in patients
receiving rituximab products. Discontinue infusions for serious or
life-threatening cardiac arrhythmias. Perform cardiac monitoring
during and after all infusions of RIABNITM for patients
who develop clinically significant arrhythmias, or who have a
history of arrhythmia or angina.
Renal Toxicity
- Severe, including fatal, renal toxicity can occur after
rituximab product administration in patients with NHL. Renal
toxicity has occurred in patients who experience TLS and in
patients with NHL administered concomitant cisplatin therapy during
clinical trials. The combination of cisplatin and
RIABNITM is not an approved treatment regimen. Monitor
closely for signs of renal failure and discontinue
RIABNITM in patients with a rising serum creatinine or
oliguria.
Bowel Obstruction and Perforation
- Abdominal pain, bowel obstruction and perforation, in some
cases leading to death, can occur in patients receiving rituximab
products in combination with chemotherapy. In postmarketing
reports, the mean time to documented gastrointestinal perforation
was 6 (range 1−77) days in patients with NHL. Evaluate if symptoms
of obstruction such as abdominal pain or repeated vomiting
occur.
Immunization
- The safety of immunization with live viral vaccines following
rituximab product therapy has not been studied, and vaccination
with live virus vaccines is not recommended before or during
treatment.
- For patients treated with RIABNITM, physicians
should review the patient's vaccination status and patients should,
if possible, be brought up to date with all immunizations in
agreement with current immunization guidelines prior to initiating
RIABNITM; administer non-live vaccines at least 4 weeks
prior to a course of RIABNITM.
Embryo-Fetal Toxicity
- Based on human data, rituximab products can cause fetal harm
due to B-cell lymphocytopenia in infants exposed in utero. Advise
pregnant women of the potential risk to a fetus. Advise females of
reproductive potential to use effective contraception with
RIABNITM and for at least 12 months after the last
dose.
Concomitant Use with Other Biologic Agents and Disease
Modifying Antirheumatic Drugs (DMARDs) in GPA and
MPA
- Limited data are available on the safety of the use of biologic
agents or DMARDs. Observe patients closely for signs of infection
if biologic agents and/or DMARDs are used concomitantly. Use of
concomitant immunosuppressants other than corticosteroids has not
been studied in GPA or MPA patients exhibiting peripheral B-cell
depletion following treatment with rituximab products.
Adverse Reactions
- The most common Grade 3 or 4 adverse reactions in clinical
trials of NHL and chronic lymphocytic leukemia (CLL) were
infusion-related reactions, neutropenia, leukopenia, anemia,
thrombocytopenia, and infections. Additionally, lymphopenia and
lung disorder were seen in NHL trials; and febrile neutropenia,
pancytopenia, hypotension, and hepatitis B were seen in CLL
trials.
- The most common adverse reactions (incidence ≥25%) in clinical
trials of NHL and CLL were infusion-related reactions.
Additionally, fever, lymphopenia, chills, infection, and asthenia
were seen in NHL trials; and neutropenia was seen in CLL
trials.
Nursing Mothers
- There are no data on the presence of rituximab products in
human milk, the effect on the breastfed child, or the effect on
milk production. Because of the potential of serious adverse
reactions in the breastfed child, advise women not to breastfeed
during treatment with RIABNITM and for at least 6 months
after the last dose.
Clinical Trials Experience in GPA and MPA
- Adverse reactions reported in ≥15% of rituximab-treated
patients were infections, nausea, diarrhea, headache, muscle
spasms, anemia, and peripheral edema (other important adverse
reactions include infusion-related reactions).
Induction Treatment of Patients with Active GPA/MPA (GPA/MPA
Study 1)
Infusion-Related Reactions
- In GPA/MPA Study 1, 12% vs 11% (rituximab-treated vs
cyclophosphamide-treated, respectively) of patients experienced at
least one infusion-related reaction. Infusion-related reactions
included cytokine release syndrome, flushing, throat irritation,
and tremor. In the rituximab group, the proportion of patients
experiencing an infusion reaction was 12%, 5%, 4%, and 1% following
the first, second, third, and fourth infusions, respectively.
Patients were premedicated with antihistamine and acetaminophen
before each rituximab infusion and were on background oral
corticosteroids, which may have mitigated or masked an
infusion-related reaction; however, there is insufficient evidence
to determine whether premedication diminishes the frequency or
severity of infusion-related reactions.
Infections
- In GPA/MPA Study 1, 62% vs 47% (rituximab-treated vs
cyclophosphamide-treated, respectively) of patients experienced an
infection by Month 6. The most common infections in the rituximab
group were upper respiratory tract infections, urinary tract
infections, and herpes zoster. The incidence of serious infections
was 11% vs 10% (rituximab-treated vs cyclophosphamide-treated,
respectively), with rates of approximately 25 and 28 per 100
patient-years, respectively. The most common serious infection was
pneumonia.
Hypogammaglobulinemia
- Hypogammaglobulinemia (IgA, IgG, or IgM below the lower limit
of normal) has been observed in patients with GPA and MPA treated
with rituximab in GPA/MPA Study 1. At 6 months, in the rituximab
group, 27%, 58%, and 51% of patients with normal immunoglobulin
levels at baseline had low IgA, IgG, and IgM levels, respectively,
compared to 25%, 50%, and 46% in the cyclophosphamide group.
Immunogenicity
- A total of 23/99 (23%) rituximab-treated adult patients with
GPA or MPA tested positive for anti-rituximab antibodies by 18
months in GPA/MPA Study 1. The clinical relevance of anti-rituximab
antibody formation in rituximab-treated adult patients is
unclear.
Treatment of Patients with GPA/MPA Who Have Achieved Disease
Control with Induction Treatment (GPA/MPA Study 2)
- In GPA/MPA Study 2, the safety profile was consistent with the
known safety profile of rituximab in immunologic indications.
Infusion-Related Reactions (IRR)
- In GPA/MPA Study 2, 7/57 (12%) patients in the non-US-licensed
approved rituximab arm reported infusion-related reactions. The
incidence of IRR symptoms was highest during or after the first
infusion (9%) and decreased with subsequent infusions (<4%). One
patient had two serious IRRs; two IRRs led to a dose modification;
and no IRRs were severe, fatal, or led to withdrawal from the
study.
Infections
- In GPA/MPA Study 2, 30/57 (53%) patients in the non-US-licensed
approved rituximab arm and 33/58 (57%) in the azathioprine arm
reported infections. The incidence of all-grade infections was
similar between the arms. The incidence of serious infections was
similar in both arms (12%). The most commonly reported serious
infection in the group was mild or moderate bronchitis.
Attention Healthcare Provider: Provide Medication Guide to
patient prior to RIABNITM infusion and advise patients
to read guide.
You may report side effects to the FDA at (800) FDA-1088
or www.fda.gov/medwatch. You may also report side
effects to Amgen at 1-800-772-6436.
Please see the full Prescribing Information,
including BOXED WARNINGS and Medication Guide, for
additional Important Safety Information.
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Rituxan® is a registered trademark of Biogen.
Truxima® is a registered trademark of Celltrion Inc.
Ruxience® is a trademark of Pfizer Inc.
CONTACT: Amgen, Thousand Oaks
Kelley Davenport, 202-585-9637
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