Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that its
collaborator, Takeda Pharmaceutical Company Limited, received
approval from the European Commission to extend the marketing
authorization for ADCETRIS (brentuximab vedotin) to include
ADCETRIS in combination with AVD (Adriamycin®, vinblastine and
dacarbazine) in adults patients with previously untreated CD30+
stage IV classical Hodgkin lymphoma (HL). The decision follows a
positive opinion from the Committee for Medicinal Products for
Human Use (CHMP) on December 13, 2018. As a result, Seattle
Genetics will receive a milestone payment from Takeda of $30
million. ADCETRIS is an antibody-drug conjugate (ADC) directed to
CD30, a defining marker of classical HL that plays a role in tumor
growth and survival.
“Receipt of this milestone payment reflects continued progress
by our partner Takeda to expand ADCETRIS approved indications
globally,” said Clay Siegall, Ph.D., President and Chief Executive
Officer at Seattle Genetics. “We look forward to continuing our
work with Takeda to establish ADCETRIS as the global foundation of
care for CD30-expressing lymphomas, including Hodgkin
lymphoma.”
The marketing authorization for ADCETRIS is based on positive
results from the ECHELON-1 phase 3 clinical trial that were
presented in the Plenary Scientific Session at the 59th American
Society of Hematology (ASH) annual meeting in December 2017 with
simultaneous publication in the New England Journal of
Medicine.
In September 2018, the Japanese Ministry of Health, Labour and
Welfare approved ADCETRIS in combination with AVD as a frontline
treatment option for CD30-positive HL patients in Japan. In March
2018, the U.S. Food and Drug Administration (FDA) approved ADCETRIS
in combination with AVD for the treatment of adult patients with
previously untreated stage III or IV classical HL based on the
positive results of the ECHELON-1 phase 3 clinical trial.
For more information about the European Commission decision,
please visit the European Medicines Agency website:
www.ema.europa.eu/ema.
About Classical 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. Classical
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.
According to the Lymphoma Coalition, over 62,000 people
worldwide are diagnosed with Hodgkin lymphoma each year and
approximately 25,000 people die each year from this cancer.
About ADCETRIS (brentuximab vedotin)
ADCETRIS is being evaluated broadly in more than 70 clinical
trials in CD30-expressing lymphomas. These include three completed
phase 3 trials: ECHELON-2 in frontline peripheral T-cell lymphomas,
ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in
cutaneous T-cell lymphoma. The phase 3 CHECKMATE 812 trial of
ADCETRIS in combination with Opdivo (nivolumab) for
relapsed/refractory Hodgkin lymphoma is ongoing.
ADCETRIS 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 Seattle Genetics’
proprietary technology. 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 for injection for intravenous infusion has received FDA
approval for six indications in adult patients with: (1) previously
untreated systemic anaplastic large cell lymphoma (sALCL) or other
CD30-expressing peripheral T-cell lymphomas (PTCL), including
angioimmunoblastic T-cell lymphoma and PTCL not otherwise
specified, in combination with cyclophosphamide, doxorubicin, and
prednisone, (2) previously untreated Stage III or IV classical
Hodgkin lymphoma (cHL), in combination with doxorubicin,
vinblastine, and dacarbazine, (3) cHL at high risk of relapse or
progression as post-autologous hematopoietic stem cell
transplantation (auto-HSCT) consolidation, (4) cHL after failure of
auto-HSCT or failure of at least two prior multi-agent chemotherapy
regimens in patients who are not auto-HSCT candidates, (5) sALCL
after failure of at least one prior multi-agent chemotherapy
regimen, and (6) primary cutaneous anaplastic large cell lymphoma
(pcALCL) or CD30-expressing mycosis fungoides (MF) who have
received prior systemic therapy.
Health Canada granted ADCETRIS approval with conditions for
relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and
non-conditional approval for post-autologous stem cell
transplantation (ASCT) consolidation treatment of Hodgkin lymphoma
patients at increased risk of relapse or progression in 2017, and
adults with pcALCL or CD30-expressing MF who have had prior
systemic therapy in 2018.
ADCETRIS received conditional marketing authorization from the
European Commission in October 2012. The approved indications in
Europe are: (1) for the treatment of adult patients with relapsed
or refractory CD30-positive Hodgkin lymphoma following ASCT, or
following at least two prior therapies when ASCT or multi-agent
chemotherapy is not a treatment option, (2) the treatment of adult
patients with relapsed or refractory sALCL, (3) for the treatment
of adult patients with CD30-positive Hodgkin lymphoma at increased
risk of relapse or progression following ASCT, and (4) for the
treatment of adult patients with CD30-positive cutaneous T-cell
lymphoma (CTCL) after at least one prior systemic therapy.
ADCETRIS has received marketing authorization by regulatory
authorities in 72 countries for relapsed or refractory Hodgkin
lymphoma and sALCL. See select important safety information,
including Boxed Warning, below.
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 Seattle Genetics
Seattle Genetics, Inc. is an emerging multi-product, global
biotechnology company that develops and commercializes
transformative therapies targeting cancer to make a meaningful
difference in people’s lives. ADCETRIS® (brentuximab vedotin)
utilizes the company’s industry-leading antibody-drug conjugate
(ADC) technology and is currently approved for the treatment of
multiple CD30-expressing lymphomas. Beyond ADCETRIS, the company
has established a pipeline of novel targeted therapies at various
stages of clinical testing, including three in ongoing pivotal
trials for solid tumors. Enfortumab vedotin for metastatic
urothelial cancer and tisotumab vedotin for metastatic cervical
cancer utilize our proprietary ADC technology. Tucatinib, a small
molecule tyrosine kinase inhibitor, is in a pivotal trial for
HER2-positive metastatic breast cancer. In addition, we are
leveraging our expertise in empowered antibodies to build a
portfolio of proprietary immuno-oncology agents in clinical trials
targeting hematologic malignancies and solid tumors. The company is
headquartered in Bothell, Washington, and has a European office in
Switzerland. For more information on our robust pipeline, visit
www.seattlegenetics.com and follow @SeattleGenetics on Twitter.
ADCETRIS (brentuximab vedotin) Important Safety
Information
BOXED WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
(PML):
JC virus infection resulting in PML and death can occur in
ADCETRIS-treated patients.
Contraindication
ADCETRIS concomitant with bleomycin due to pulmonary toxicity
(e.g., interstitial infiltration and/or inflammation).
Warnings and Precautions
- Peripheral neuropathy (PN):
ADCETRIS causes PN that is predominantly sensory. Cases of motor PN
have also been reported. ADCETRIS-induced PN is cumulative. Monitor
for symptoms such as hypoesthesia, hyperesthesia, paresthesia,
discomfort, a burning sensation, neuropathic pain, or weakness.
Institute dose modifications accordingly.
- Anaphylaxis and infusion
reactions: Infusion-related reactions (IRR), including
anaphylaxis, have occurred with ADCETRIS. Monitor patients during
infusion. If an IRR occurs, interrupt the infusion and institute
appropriate medical management. If anaphylaxis occurs, immediately
and permanently discontinue the infusion and administer appropriate
medical therapy. Premedicate patients with a prior IRR before
subsequent infusions. Premedication may include acetaminophen, an
antihistamine, and a corticosteroid.
- Hematologic toxicities: Fatal
and serious cases of febrile neutropenia have been reported with
ADCETRIS. Prolonged (≥1 week) severe neutropenia and Grade 3 or 4
thrombocytopenia or anemia can occur with ADCETRIS. Start primary
prophylaxis with G-CSF beginning with Cycle 1 for patients who
receive ADCETRIS in combination with chemotherapy for previously
untreated Stage III or IV classical HL or previously untreated
PTCL. Monitor complete blood counts prior to each ADCETRIS dose.
Monitor more frequently for patients with Grade 3 or 4 neutropenia.
Monitor patients for fever. If Grade 3 or 4 neutropenia develops,
consider dose delays, reductions, discontinuation, or G-CSF
prophylaxis with subsequent ADCETRIS doses.
- Serious infections and opportunistic
infections: Infections such as pneumonia, bacteremia, and
sepsis or septic shock (including fatal outcomes) have been
reported in ADCETRIS-treated patients. Closely monitor patients
during treatment for bacterial, fungal, or viral infections.
- Tumor lysis syndrome: Closely
monitor patients with rapidly proliferating tumor and high tumor
burden.
- Increased toxicity in the presence
of severe renal impairment: The frequency of ≥Grade 3 adverse
reactions and deaths was greater in patients with severe renal
impairment compared to patients with normal renal function. Avoid
use in patients with severe renal impairment.
- Increased toxicity in the presence
of moderate or severe hepatic impairment: The frequency of
≥Grade 3 adverse reactions and deaths was greater in patients with
moderate or severe hepatic impairment compared to patients with
normal hepatic function. Avoid use in patients with moderate or
severe hepatic impairment.
- Hepatotoxicity: Fatal and
serious cases have occurred in ADCETRIS-treated patients. Cases
were consistent with hepatocellular injury, including elevations of
transaminases and/or bilirubin, and occurred after the first
ADCETRIS dose or rechallenge. Preexisting liver disease, elevated
baseline liver enzymes, and concomitant medications may increase
the risk. Monitor liver enzymes and bilirubin. Patients with new,
worsening, or recurrent hepatotoxicity may require a delay, change
in dose, or discontinuation of ADCETRIS.
- PML: Fatal cases of JC virus
infection resulting in PML and death have been reported in
ADCETRIS-treated patients. First onset of symptoms occurred at
various times from initiation of ADCETRIS therapy, with some cases
occurring within 3 months of initial exposure. Other possible
contributory factors other than ADCETRIS include prior therapies
and underlying disease that may cause immunosuppression. Consider
PML diagnosis in patients with new-onset signs and symptoms of
central nervous system abnormalities. Hold ADCETRIS if PML is
suspected and discontinue ADCETRIS if PML is confirmed.
- Pulmonary toxicity: Fatal and
serious events of noninfectious pulmonary toxicity including
pneumonitis, interstitial lung disease, and acute respiratory
distress syndrome have been reported. Monitor patients for signs
and symptoms, including cough and dyspnea. In the event of new or
worsening pulmonary symptoms, hold ADCETRIS dosing during
evaluation and until symptomatic improvement.
- Serious dermatologic reactions:
Fatal and serious cases of Stevens-Johnson syndrome (SJS) and toxic
epidermal necrolysis (TEN) have been reported with ADCETRIS. If SJS
or TEN occurs, discontinue ADCETRIS and administer appropriate
medical therapy.
- Gastrointestinal (GI)
complications: Fatal and serious cases of acute pancreatitis
have been reported. Other fatal and serious GI complications
include perforation, hemorrhage, erosion, ulcer, intestinal
obstruction, enterocolitis, neutropenic colitis, and ileus.
Lymphoma with preexisting GI involvement may increase the risk of
perforation. In the event of new or worsening GI symptoms, perform
a prompt diagnostic evaluation and treat appropriately.
- Embryo-fetal toxicity: Based on
the mechanism of action and animal studies, ADCETRIS can cause
fetal harm. Advise females of reproductive potential of the
potential risk to the fetus, and to avoid pregnancy during ADCETRIS
treatment and for at least 6 months after the final dose of
ADCETRIS.
Most Common (≥20% in any study) Adverse Reactions:
Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia,
upper respiratory tract infection, pyrexia, constipation, vomiting,
alopecia, decreased weight, abdominal pain, anemia, stomatitis,
lymphopenia and mucositis.
Drug Interactions
Concomitant use of strong CYP3A4 inhibitors or inducers has the
potential to affect the exposure to monomethyl auristatin E
(MMAE).
Use in Specific Populations
Moderate or severe hepatic impairment or severe renal
impairment: MMAE exposure and adverse reactions are increased.
Avoid use.
Advise males with female sexual partners of reproductive
potential to use effective contraception during ADCETRIS treatment
and for at least 6 months after the final dose of ADCETRIS.
Advise patients to report pregnancy immediately and avoid
breastfeeding while receiving ADCETRIS.
For additional Important Safety Information, including BOXED
WARNING, please see the full Prescribing Information for ADCETRIS
at www.seattlegenetics.com or
http://www.ADCETRIS.com.
Forward-Looking Statements
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the potential
benefit and use of ADCETRIS (brentuximab vedotin), the goal of
establishing ADCETRIS as the global foundation of care for
CD30-expressing lymphomas and the anticipated payment of a
milestone payment by Takeda. Actual results or developments may
differ materially from those projected or implied in these
forward-looking statements due to factors such as utilization and
adoption of the approved treatment regimen by prescribing
physicians, competitive conditions including the availability of
alternative treatment regimens, the availability and extent of
reimbursement, the risk of adverse events, adverse regulatory
action and unanticipated delays or other obstacles preventing the
timely receipt of Takeda’s collaboration payments. More information
about the risks and uncertainties faced by Seattle Genetics is
contained under the caption “Risk Factors” included in the
company’s Annual Report on Form 10-K for the year ended December
31, 2018 filed with the Securities and Exchange
Commission. Seattle Genetics disclaims any intention or
obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20190211005174/en/
Seattle GeneticsInvestors:Peggy Pinkston(425)
527-4160ppinkston@seagen.com
Media:Monique Greer(425) 527-4641mgreer@seagen.com
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