Approval
is Based on a Phase 2 Multicenter, Open Label Study (SGN 35-006 Part A)
whose Data are Consistent with the Established Safety and Efficacy
Profile of ADCETRIS -
CAMBRIDGE, Mass. & OSAKA, Japan - Sunday, January 24th 2016 [ME NewsWire]
(BUSINESS
WIRE)-- Takeda Pharmaceutical Company Limited (TSE:4502) today
announced that the European Commission (EC) has approved a Type II
variation for ADCETRIS® (brentuximab vedotin) to include data on the
retreatment of adult patients with relapsed or refractory (R/R) Hodgkin
lymphoma or R/R systemic anaplastic large cell lymphoma (sALCL) who
previously responded to ADCETRIS and who later relapse. The decision
from the EC follows a positive opinion from the Committee for Medicinal
Products for Human Use (CHMP) in October 2015.
ADCETRIS
was granted conditional marketing authorization by the EC in 2012 for
the treatment of R/R CD30+ Hodgkin lymphoma following autologous stem
cell transplant (ASCT), or at least two prior therapies when ASCT or
multi-agent chemotherapy is not a treatment option, and for R/R sALCL.
The
SmPC variation includes an update to the clinical sections, including
safety, to include data on retreatment of adult patients who have
responded to previous treatment with ADCETRIS (CR or PR) under the
existing indications, but later relapsed.
The
Type II variation is based on data from the Phase 2 SGN35-006 Part A
study that demonstrated effective anti-tumor responses can be achieved
in the majority of R/R Hodgkin lymphoma and sALCL patients with ADCETRIS
retreatment. The safety and efficacy results from this trial were
consistent with the positive profile demonstrated in the pivotal Phase 2
studies (SGN35-003 and SGN35-004).
“ADCETRIS
has transformed the treatment landscape for relapsed/refractory Hodgkin
lymphoma and sALCL patients in Europe, and has emerged as a most
valuable tool to induce a remission. However, lymphoma is a relentless
disease, and relapse occurs in some of these very difficult to treat
patients. Now, with the opportunity for retreatment, we can offer
patients with very limited options another chance to potentially benefit
from ADCETRIS,” said Professor Anton Hagenbeek, M.D., Ph.D., Professor
of Hematology, Department of Hematology, Academic Medical Center in the
University of Amsterdam.
“The EC decision to
include data on retreatment in the ADCETRIS label is important in
advancing care for patients battling these diseases,” said Dirk Huebner,
M.D., Executive Medical Director, Oncology Therapeutic Area Unit,
Takeda. “We look forward to continuing our ongoing clinical program of
ADCETRIS in Hodgkin lymphoma and sALCL, as well as in a variety of other
forms of lymphoma, with the goal of bringing this important therapy to
patients who might benefit from it.”
For further details about the EC decision, please visit the EMA website: www.ema.europa.eu/ema.
SGN35-006 Part A Study
The
SGN35-006 Part A study, entitled “Treatment with SGN-35 in patients
with CD30-positive hematologic malignancies who have previously
participated in an SGN-35 study,” was a Phase 2, multicenter, open-label
study. The study was designed to evaluate ADCETRIS retreatment in
patients with Hodgkin lymphoma (20 patients) or sALCL (8 patients) that
recurred after a previous response to ADCETRIS (Part A). Primary
objectives were safety and anti-tumor response. Secondary objectives
were duration of tumor control, including duration of response and
progression-free survival (PFS), overall survival (OS) and incidence of
anti-therapeutic antibodies (ATA).
For more information about the trial, please visit www.clinicaltrialsregister.eu.
About Hodgkin Lymphoma
Lymphoma
is a general term for a group of cancers that originate in the
lymphatic system. There are two major categories of lymphoma: Hodgkin
lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished
from other types of lymphoma by the presence of one characteristic type
of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell
expresses CD30.
About Anaplastic Large Cell Lymphoma
Anaplastic
Large Cell Lymphoma (ALCL) is a type of aggressive T-cell lymphoma,
comprising about 3 percent of all non-Hodgkin lymphomas (NHL) in adults
and between 10 and 30 percent of all NHL in children. There are two
distinct forms/types of ALCL, including primary cutaneous ALCL and
systemic ALCL (sALCL). sALCL is a clinically aggressive, systemic
lymphoma that primarily involves lymph nodes and expresses CD30.
About ADCETRIS
ADCETRIS®
(brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal
antibody attached by a protease-cleavable linker to a microtubule
disrupting agent, monomethyl auristatin E (MMAE), utilizing proprietary
technology by Seattle Genetics. The ADC employs a linker system that is
designed to be stable in the bloodstream but to release MMAE upon
internalization into CD30-expressing tumor cells.
ADCETRIS
was granted conditional marketing authorization by the European
Commission in October 2012 for two indications: (1) for the treatment of
adult patients with relapsed or refractory CD30-positive Hodgkin
lymphoma following autologous stem cell transplant (ASCT), or following
at least two prior therapies when ASCT or multi-agent chemotherapy is
not a treatment option, and (2) the treatment of adult patients with
relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
In January 2016, the European Commission approved a Type II variation to
include data on the retreatment of adult patients with Hodgkin lymphoma
or sALCL who previously responded to ADCETRIS and who later relapse.
ADCETRIS has received marketing authorization by regulatory authorities
in more than 60 countries. See important safety information below.
ADCETRIS
is being evaluated broadly in more than 45 ongoing clinical trials,
including the Phase 3 ALCANZA trial and two additional Phase 3 studies,
one in frontline classical Hodgkin lymphoma and one in frontline mature
T-cell lymphomas, as well as trials in many additional types of
CD30-expressing malignancies, including B-cell lymphomas.
Seattle
Genetics and Takeda are jointly developing ADCETRIS. Under the terms of
the collaboration agreement, Seattle Genetics has U.S. and Canadian
commercialization rights and Takeda has rights to commercialize ADCETRIS
in the rest of the world. Seattle Genetics and Takeda are funding joint
development costs for ADCETRIS on a 50:50 basis, except in Japan where
Takeda is solely responsible for development costs.
About Takeda
Located
in Osaka, Japan, Takeda (TSE: 4502) is a research-based global company
with its main focus on pharmaceuticals. As the largest pharmaceutical
company in Japan and one of the global leaders of the industry, Takeda
is committed to strive towards better health for people worldwide
through leading innovation in medicine. Additional information about
Takeda is available through its corporate website, www.takeda.com.
ADCETRIS Global Important Safety Information
ADCETRIS® is indicated for the treatment of adult patients with relapsed or refractory (r/r) CD30+ Hodgkin lymphoma:
1. Following autologous stem cell transplant or
2. Following at least 2 prior therapies when autologous stem cell transplantation is not a treatment option
ADCETRIS
is indicated for the treatment of adult patients with relapsed or
refractory systemic anaplastic large cell lymphoma (sALCL).
ADCETRIS
is contraindicated for patients who are hypersensitive to ADCETRIS. In
addition, combined use of bleomycin and ADCETRIS causes pulmonary
toxicity, and is contraindicated.
ADCETRIS can cause serious side effects, including:
Progressive multifocal leukoencephalopathy (PML): John Cunningham
virus (JCV) reactivation resulting in PML and death has been reported in
patients treated with ADCETRIS. Patients should be closely monitored
for new or worsening neurological, cognitive, or behavioral signs or
symptoms, which may be suggestive of PML.
Pancreatitis:
Acute pancreatitis has been observed in patients treated with ADCETRIS.
Fatal outcomes have been reported. Patients should be closely monitored
for new or worsening abdominal pain.
Pulmonary Toxicity:
Cases of pulmonary toxicity have been reported in patients receiving
ADCETRIS. In the event of new or worsening pulmonary symptoms (e.g.,
cough, dyspnoea), a prompt diagnostic evaluation should be performed.
Serious infections and opportunistic infections: Serious infections
such as pneumonia, staphylococcal bacteraemia, sepsis/septic shock
(including fatal outcomes), and herpes zoster, and opportunistic
infections such as Pneumocystis jiroveci pneumonia and oral candidiasis
have been reported in patients treated with ADCETRIS. Patients should be
carefully monitored during treatment for emergence of possible serious
and opportunistic infections.
Infusion-related reactions:
Immediate and delayed infusion-related reactions, as well as
anaphylaxis, have occurred with ADCETRIS. Patients should be carefully
monitored during and after an infusion.
Tumor lysis
syndrome (TLS): TLS has been reported with ADCETRIS. Patients with
rapidly proliferating tumor and high tumor burden are at risk of TLS and
should be monitored closely and managed according to best medical
practice.
Peripheral neuropathy (PN): ADCETRIS treatment
may cause PN that is predominantly sensory. Cases of peripheral motor
neuropathy have also been reported. Patients should be monitored for
symptoms of PN, such as hypoesthesia, hyperesthesia, paresthesia,
discomfort, a burning sensation, neuropathic pain, or weakness.
Hematological toxicities: Grade 3 or Grade 4 anemia,
thrombocytopenia, and prolonged (equal to or greater than one week)
Grade 3 or Grade 4 neutropenia can occur with ADCETRIS. Complete blood
counts should be monitored prior to administration of each dose.
Febrile neutropenia: Febrile neutropenia has been reported. Patients
should be monitored closely for fever and managed according to best
medical practice.
Stevens-Johnson syndrome (SJS) and Toxic
Epidermal Necrolysis (TEN): SJS and TEN have been reported. Fatal
outcomes have been reported.
Hyperglycemia: Hyperglycemia
has been reported during trials in patients with an elevated body mass
index (BMI) with or without a history of diabetes mellitus. Any patient
who experiences an event of hyperglycemia should have their serum
glucose closely monitored.
Renal and hepatic impairment:
There is limited experience in patients with renal and hepatic
impairment. Population pharmacokinetic analysis indicated that MMAE
clearance might be affected by moderate and severe renal impairment, and
by low serum albumin concentrations. Elevations in alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) have been
reported. Liver function should be routinely monitored in patients
receiving brentuximab vedotin.
Sodium content in
excipients: This medicinal product contains a maximum of 2.1 mmol (or
47mg) of sodium per dose. To be taken into consideration for patients on
a controlled sodium diet.
Serious adverse drug
reactions were: neutropenia, thrombocytopenia, constipation, diarrhea,
vomiting, pyrexia, peripheral motor neuropathy and peripheral sensory
neuropathy, hyperglycemia, demyelinating polyneuropathy, tumor lysis
syndrome, and Stevens-Johnson syndrome.
ADCETRIS
was studied as monotherapy in 160 patients in two Phase 2 studies.
Across both studies, adverse reactions defined as very common (≥1/10)
were: infections, neutropenia, peripheral sensory neuropathy, diarrhea,
nausea, vomiting, alopecia, pruritis, myalgia, fatigue, pyrexia, and
infusion-related reactions. Adverse reactions defined as common (≥1/100
to <1/10) were: upper respiratory tract infection, herpes zoster,
pneumonia, anemia, thrombocytopenia, hyperglycemia, peripheral motor
neuropathy, dizziness, demyelinating polyneuropathy, cough, dyspnea,
constipation, rash, arthralgia, back pain, and chills.
These
are not all of the possible side effects with ADCETRIS. Please refer to
Summary of Product Characteristics (SmPC) before prescribing.
Contacts
Takeda Pharmaceutical Company Limited
Japanese Media
Tsuyoshi Tada, +81 (0) 3-3278-2417
tsuyoshi.tada@takeda.com
or
European Media
Kate Burd, +41 79 514 9533
kate.burd@takeda.com
or
Media Outside Japan and Europe:
Elizabeth Pingpank, +1-617-444-1495
elizabeth.pingpank@takeda.com
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