NORTH CHICAGO, Ill.,
Nov. 21, 2017 /PRNewswire/
-- AbbVie (NYSE: ABBV), a global research and
development-based biopharmaceutical company, today announced that
the American Society of Hematology (ASH) has accepted data from the
Phase 3 MURANO study evaluating venetoclax tablets in combination
with rituximab in patients with relapsed/refractory chronic
lymphocytic leukemia (R/R CLL), as an oral, late-breaking
presentation during the upcoming 59th ASH Annual Meeting
& Exposition, December 9-12, in
Atlanta, GA. The abstract is one
of six late-breaking abstracts accepted for presentation at the
meeting.
In total, 28 AbbVie abstracts have been accepted for ASH 2017.
These abstracts include data from investigational studies of the
company's portfolio of medicines for investigational or new use in
various blood cancers and diseases, including CLL, acute myeloid
leukemia (AML), multiple myeloma (MM) and chronic
graft-versus-host-disease (cGVHD), among others.
Data will be presented about venetoclax, a B-cell lymphoma-2
(BCL-2) inhibitor, being developed by AbbVie and Genentech, a
member of the Roche Group; ibrutinib, an inhibitor of Bruton's
tyrosine kinase (BTK) being developed by Pharmacyclics, an AbbVie
company, and Janssen Biotech, Inc.; elotuzumab, an
immunostimulatory antibody that specifically targets Signaling
Lymphocyte Activation Molecule Family member 7 (SLAMF7), a
cell-surface glycoprotein co-developed by Bristol-Myers Squibb and
AbbVie; and other early-stage investigational compounds.
"Our data presentations at this year's ASH Annual Meeting
underscore our continued commitment to patients and deep expertise
in researching hematologic malignancies across various
difficult-to-treat blood cancers," said Gary Gordon, M.D., Ph.D., vice president,
oncology clinical development, AbbVie. "We are especially
encouraged by the Phase 3 venetoclax data that ASH accepted for
presentation in the late-breaking abstract session. We believe
clinical study data for this medicine show the potential of
improving treatment across a wide range of blood cancers, including
CLL."
Venetoclax clinical data will also be featured in the 2018
"Highlights of ASH" meeting series. These symposia, which are held
in the United States, Asia-Pacific and Latin America, feature select hematology
research presented at the most recent ASH Annual Meeting in an
effort to improve patient management and care strategies.
AbbVie abstracts:
Ibrutinib
- Single-agent Ibrutinib vs Chemoimmunotherapy Regimens for
Treatment-naïve Patients with Chronic Lymphocytic Leukemia (CLL): A
Cross-trial Comparison; Robak et al.; Abstract 1750; Poster
Session; Saturday, December 9;
5:30-7:30 p.m. ET
- Prolonged Improvement in Patient-reported Outcomes (PROs)
and Well-being in Older Patients with Treatment-naïve (TN) Chronic
Lymphocytic Leukemia Treated with Ibrutinib (Ibr): 3-year Follow-up
of the RESONATE-2 Study; Tedeschi et al.; Abstract 1746; Poster
Session; Saturday, December 9;
5:30-7:30 p.m. ET
- Incidence of and Risk Factors for Major Hemorrhage in
Patients Treated with Ibrutinib: Results from an Integrated
Analysis; Brown et al.; Abstract 1743; Poster Session;
Saturday, December 9; 5:30-7:30 p.m. ET
- Ibrutinib Therapy in Patients with Relapsed/Refractory
Marginal Zone Lymphoma: Analysis by Prior Rituximab Treatment and
Baseline Mutations; Chen et al.; Abstract 3026; Poster Session;
Sunday, December 10; 6:00-8:00 p.m. ET
- Initial Phase 2 Results of Ibrutinib Combined with
Carfilzomib/Dexamethasone in Patients with Relapsed/Refractory
Multiple Myeloma; Chari et al.; Abstract 3111; Poster Session;
Sunday, December 10; 6:00-8:00 p.m. ET
- Ibrutinib Inhibits cGVHD Pathogenic Pre-germinal Center
B-cells and Follicular Helper Cells While Preserving Immune Memory
and Th1 T-cells; Sahaf et al.; Abstract 4481; Poster Session;
Monday, December 11; 6:00-8:00 p.m. ET
- Tolerability and Outcomes of Ibrutinib-treated Patients in
Canada: Retrospective Analysis of
Real World Patients; Merali et al.; Online Publication
Venetoclax
- Venetoclax Plus Rituximab is Superior to Bendamustine Plus
Rituximab in Patients with Relapsed/ Refractory Chronic Lymphocytic
Leukemia - Results from Pre-planned Interim Analysis of the
Randomized Phase 3 Murano Study; Seymour et al.; Abstract
109076; Late-Breaking Abstract Oral Session; Tuesday, December 12; 7:45
a.m. ET
- Sequencing Therapy in Chronic Lymphocytic Leukemia (CLL):
Treatment Patterns and Associated Outcomes in Community Practice
for Patients with Relapsed/Refractory CLL in the United States; Kapustyan et al.;
Abstract 1749; Poster Session; Saturday,
December 9; 5:30-7:30 p.m.
ET
- Do Statins Enhance the Anti-cancer Activity of Venetoclax?;
Roberts et al.; Abstract 1737;
Poster Session; Saturday, December 9;
5:30-7:30 p.m. ET
- Clinical Benefits of Achieving Deep Remission to Second-line
Therapy in Patients with Relapsed/Refractory (R/R) Chronic
Lymphocytic Leukemia (CLL) – a Real-world Study; Wierda et al.;
Abstract 2130; Poster Session; Saturday,
December 9; 5:30-7:30 p.m.
ET
- BCL2 Expression Identifies a Population with Unmet Medical
Need in Previously Untreated (1L) Patients with DLBCL;
Szafer-Glusman et al.; Abstract 418; Oral Session;
Sunday, December 10; 12:45 p.m. ET
- Safety, Efficacy and MRD Negativity of a Combination of
Venetoclax and Obinutuzumab in Patients with Previously Untreated
Chronic Lymphocytic Leukemia – Results from a Phase 1b Study
(GP28331); Flinn et al.; Abstract 430; Oral Session;
Sunday, December 10; 12:45 p.m. ET
- A Simulation Analysis to Evaluate the Effect of Prospective
Biomarker Testing on Progression-free Survival (PFS) in DLBCL;
Szafer-Glusman et al.; Abstract 419; Oral Session; Sunday, December 10; 1:00
p.m. ET
- Phase 1 Study of Venetoclax in Combination with
Dexamethasone as Targeted Therapy for t(11;14) Relapsed/Refractory
Multiple Myeloma; Kaufman et al.; Abstract 3131; Poster
Session; Sunday, December 10;
6:00-8:00 p.m. ET
- Updated Safety and Efficacy of Venetoclax with Decitabine or
Azacitidine in Treatment-naive, Elderly Patients with Acute Myeloid
Leukemia; DiNardo et al.; Abstract 2628; Poster Session;
Sunday, December 10; 6:00-8:00 p.m. ET
- Venetoclax (VEN) is Active in CLL Relapsed or Refractory to
More Than One B-cell Receptor Pathway Inhibitor (BCRi); Wierda et
al.; Abstract 3025; Poster Session; Sunday, December 10; 6:00-8:00 p.m. ET
- Preliminary Results from a Phase Ib Study Evaluating BCL-2
Inhibitor Venetoclax in Combination with MEK Inhibitor Cobimetinib
or MDM2 Inhibitor Idasanutlin in Patients with Relapsed or
Refractory (R/R) AML; Daver et al.; Abstract 813; Oral Session;
Monday, December 11; 5:00 p.m. ET
- Analysis of PET-CT to Identify Richter's Transformation in
167 Patients with Disease Progression Following Kinase-inhibitor
Therapy; Mato et al.; Abstract 834; Oral Session; Monday, December 11; 5:45
p.m. ET
- Phase 1/2 Study of Venetoclax With Low-dose Cytarabine in
Treatment-Naive, Elderly Patients with Acute Myeloid Leukemia Unfit
for Standard Induction Therapy: Long-term Outcomes; Wei et al.;
Abstract 890; Oral Session; Monday, December
11; 6:30 p.m. ET
- Drivers of Treatment Patterns in Patients with Chronic
Lymphocytic Leukemia (CLL) Treated with B-cell Receptor Inhibitors
(BCRis) – A Medical Chart Review Study; Mato et al.; Abstract
4681; Poster Session; Monday, December
11; 6:00-8:00 p.m. ET
- Impact of Number of Prior Therapies and Bulk of Disease on
Outcomes with Venetoclax (VEN) Monotherapy for Relapsed/Refractory
Chronic Lymphocytic Leukemia (CLL); Wierda et al.; Abstract
4329; Poster Session; Monday, December
11; 6:00-8:00 p.m. ET
- Sustained Minimal Residual Disease Negativity Predicted in
Chronic Lymphocytic Leukemia Patients Treated with Venetoclax
Combination Therapy for 2 Years: An Integrated Mechanistic Analysis
of Multiple Phase I and II Studies; Gopalakrishnan et al.;
Abstract 4318; Poster Session; Monday,
December 11; 6:00-8:00 p.m.
ET
- Lifetime Costs of Chronic Lymphocytic Leukemia Patients;
Sail et al.; Abstract 5621; Online Publication
- Phase 1/2 Study Evaluating the Safety, Pharmacokinetics, and
Preliminary Efficacy of Venetoclax in Japanese Subjects with
Chronic Lymphocytic Leukemia; Hatake et al.; Abstract 5352;
Online Publication
- Treatment Outcomes Among Chronic Lymphocytic Leukemia
Patients with 17p Deletion or TP53 Mutation in Argentina: A Retrospective Chart Review;
Chiattone et al.; Abstract 5617; Online Publication
Elotuzumab
- Elotuzumab Plus Lenalidomide/Dexamethasone (ELd) vs Ld in
Patients with Newly Diagnosed Multiple Myeloma: Phase 2,
Randomized, Open-label Study in Japan; Takezako et al.; Abstract 434; Oral
Session; Sunday, December 10;
12:15 p.m. ET
ABBV-621
- Abbv-621 is a Novel and Potent TRAIL Receptor Agonist Fusion
Protein that Induces Apoptosis Alone and in Combination with
Navitoclax and Venetoclax in Hematological Tumors; Tahir et
al.; Abstract 2812; Poster Session; Sunday, December 10; 6:00-8:00 p.m. ET
The ASH 2017 Annual Meeting abstracts are available at
http://www.hematology.org/Annual-Meeting/Abstracts/.
About IMBRUVICA® (ibrutinib) in the U.S.
IMBRUVICA is
a first-in-class, oral, once-daily therapy that inhibits a protein
called Bruton's tyrosine kinase (BTK). BTK is a key signaling
molecule in the B-cell receptor signaling complex that plays an
important role in the survival and spread of malignant B cells as
well as other serious, debilitating
conditions.1,2 IMBRUVICA blocks signals
that tell malignant B cells to multiply and spread
uncontrollably.1
IMBRUVICA has been granted four Breakthrough Therapy
Designations from the FDA, including in cGVHD. This designation is
intended to expedite the development and review of a potential new
drug for serious or life-threatening
diseases.3 IMBRUVICA was one of the first medicines
to receive U.S. FDA approval via the new Breakthrough Therapy
Designation pathway.
IMBRUVICA is FDA-approved in six distinct patient populations:
CLL, small lymphocytic lymphoma (SLL), Waldenström's
macroglobulinemia (WM), along with previously-treated mantle cell
lymphoma (MCL), previously-treated marginal zone lymphoma (MZL) and
cGVHD.1
- IMBRUVICA was first approved for adult patients with MCL who
have received at least one prior therapy in November 2013.
- Soon after, IMBRUVICA was initially approved in CLL patients
who have received at least one prior therapy in February 2014. By July
2014, the therapy received approval for adult CLL patients
with 17p deletion, and by March 2016,
the therapy was approved as a frontline CLL treatment.
- IMBRUVICA was approved for adult patients with WM in
January 2015.
- In May 2016, IMBRUVICA was
approved in combination with bendamustine and rituximab (BR) for
adult patients with previously treated CLL/SLL.
- In January 2017, IMBRUVICA was
approved for adult patients with MZL who require systemic therapy
and have received at least one prior anti-CD20-based therapy.
- In August 2017, IMBRUVICA was
approved for adult patients with cGVHD that failed to respond to
one or more lines of systemic therapy.
Accelerated approval was granted for the MCL and MZL indication
based on overall response rate. Continued approval for MCL and MZL
may be contingent upon verification and description of clinical
benefit in confirmatory trials.1
IMBRUVICA is being studied alone and in combination with other
treatments in several blood and solid tumor cancers and other
serious illnesses. IMBRUVICA has one of the most robust clinical
oncology development programs for a single molecule in the
industry, with more than 130 ongoing clinical trials. There are
approximately 30 ongoing company-sponsored trials, 14 of which are
in Phase 3, and more than 100 investigator-sponsored trials and
external collaborations that are active around the world. To date,
90,000 patients around the world have been treated with IMBRUVICA
in clinical practice and clinical trials.
Patient Access to IMBRUVICA
AbbVie and Janssen strive
to make access to IMBRUVICA easy by helping patients in the U.S.
understand their insurance benefits for IMBRUVICA. The YOU&i™
Support Program is a program that includes information on access
and affordability support options, nurse call support and resources
for patients being treated with IMBRUVICA.
IMBRUVICA® (ibrutinib) U.S. IMPORTANT SAFETY
INFORMATION
WARNINGS AND PRECAUTIONS
Hemorrhage: Fatal bleeding events have occurred in
patients treated with IMBRUVICA®. Grade 3 or higher bleeding events
(intracranial hemorrhage [including subdural hematoma],
gastrointestinal bleeding, hematuria, and post-procedural
hemorrhage) have occurred in up to 6% of patients. Bleeding events
of any grade, including bruising and petechiae, occurred in
approximately half of patients treated with IMBRUVICA®.
The mechanism for the bleeding events is not well
understood.
IMBRUVICA® may increase the risk of hemorrhage in patients
receiving antiplatelet or anticoagulant therapies and patients
should be monitored for signs of bleeding.
Consider the benefit-risk of withholding IMBRUVICA® for at least
3 to 7 days pre- and post-surgery depending upon the type of
surgery and the risk of bleeding.
Infections: Fatal and non-fatal infections (including
bacterial, viral, or fungal) have occurred with IMBRUVICA® therapy.
Grade 3 or greater infections occurred in 14% to 29% of patients.
Cases of progressive multifocal leukoencephalopathy (PML) and
Pneumocystis jirovecii pneumonia (PJP) have occurred in
patients treated with IMBRUVICA®. Consider prophylaxis according to
standard of care in patients who are at increased risk for
opportunistic infections.
Monitor and evaluate patients for fever and infections and treat
appropriately.
Cytopenias: Treatment-emergent Grade 3 or 4 cytopenias
including neutropenia (range, 13 to 29%), thrombocytopenia (range,
5 to 17%), and anemia (range, 0 to 13%) based on laboratory
measurements occurred in patients with B-cell malignancies treated
with single agent IMBRUVICA®.
Monitor complete blood counts monthly.
Atrial Fibrillation: Atrial fibrillation and atrial
flutter (range, 6 to 9%) have occurred in patients treated with
IMBRUVICA®, particularly in patients with cardiac risk factors,
hypertension, acute infections, and a previous history of atrial
fibrillation. Periodically monitor patients clinically for atrial
fibrillation. Patients who develop arrhythmic symptoms (e.g.,
palpitations, lightheadedness) or new onset dyspnea should have an
ECG performed. Atrial fibrillation should be managed appropriately,
and if it persists, consider the risks and benefits of IMBRUVICA®
treatment and follow dose modification guidelines.
Hypertension: Hypertension (range, 6 to 17%) has occurred
in patients treated with IMBRUVICA® with a median time to onset of
4.6 months (range, 0.03 to 22 months). Monitor patients for new
onset hypertension or hypertension that is not adequately
controlled after starting IMBRUVICA®.
Adjust existing anti-hypertensive medications and/or initiate
anti-hypertensive treatment as appropriate.
Second Primary Malignancies: Other malignancies (range, 3
to 16%) including non-skin carcinomas (range, 1 to 4%) have
occurred in patients treated with IMBRUVICA®. The most frequent
second primary malignancy was non-melanoma skin cancer (range, 2 to
13%).
Tumor Lysis Syndrome: Tumor lysis syndrome has been
infrequently reported with IMBRUVICA® therapy. Assess the baseline
risk (e.g., high tumor burden) and take appropriate
precautions.
Monitor patients closely and treat as appropriate.
Embryo-Fetal Toxicity: Based on findings in animals,
IMBRUVICA® can cause fetal harm when administered to a pregnant
woman. Advise women to avoid becoming pregnant while taking
IMBRUVICA® and for 1 month after cessation of therapy. 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
hazard to a fetus. Advise men to avoid fathering a child during the
same time period.
ADVERSE REACTIONS
B-cell malignancies: The most common adverse reactions
(≥20%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and
MZL) were thrombocytopenia (62%), neutropenia (61%), diarrhea
(43%), anemia (41%), musculoskeletal pain (30%), rash (30%),
bruising (30%), nausea (29%), fatigue (29%), hemorrhage (22%), and
pyrexia (21%).
The most common Grade 3 or 4 adverse reactions (≥5%) in patients
with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were
neutropenia (39%), thrombocytopenia (16%), and pneumonia (10%).
Approximately 6% (CLL/SLL), 14% (MCL), 11% (WM) and 10% (MZL) of
patients had a dose reduction due to adverse reactions.
Approximately 4%-10% (CLL/SLL), 9% (MCL), and 9% (WM [6%] and MZL
[13%]) of patients discontinued due to adverse reactions.
cGVHD: The most common adverse reactions (≥20%) in
patients with cGVHD were fatigue (57%), bruising (40%), diarrhea
(36%), thrombocytopenia (33%), muscle spasms (29%), stomatitis
(29%), nausea (26%), hemorrhage (26%), anemia (24%), and pneumonia
(21%).
The most common Grade 3 or 4 adverse reactions (≥5%) reported in
patients with cGVHD were fatigue (12%), diarrhea (10%), neutropenia
(10%), pneumonia (10%), sepsis (10%), hypokalemia (7%), headache
(5%), musculoskeletal pain (5%), and pyrexia (5%).
Twenty-four percent of patients receiving IMBRUVICA® in the
cGVHD trial discontinued treatment due to adverse reactions.
Adverse reactions leading to dose reduction occurred in 26% of
patients.
DRUG INTERACTIONS
CYP3A Inducers: Avoid coadministration with strong
CYP3A inducers.
CYP3A Inhibitors: Dose adjustment may be
recommended.
SPECIFIC POPULATIONS
Hepatic Impairment (based on Child-Pugh criteria): Avoid
use of IMBRUVICA® in patients with moderate or severe baseline
hepatic impairment. In patients with mild impairment, reduce
IMBRUVICA® dose.
Please see Full Prescribing Information:
https://www.imbruvica.com/prescribing-information.
About VENCLEXTA™ (venetoclax) in the U.S.
VENCLEXTA is
an oral B-cell lymphoma-2 (BCL-2) inhibitor developed by AbbVie and
Genentech, a member of the Roche Group. VENCLEXTA targets a
specific protein in the body called BCL-2.4 When
you have CLL, BCL-2 may build up and prevent cancer cells from
self-destructing naturally. VENCLEXTA targets BCL-2 in order to
help restore the process of apoptosis.4 Through
apoptosis, your body allows cancer cells and normal cells to
self-destruct.
VENCLEXTA has been granted four Breakthrough Therapy
Designations from the FDA including for the combination treatment
of patients with untreated AML not eligible for standard induction
chemotherapy. This designation is intended to expedite the
development and review of therapies for serious or life-threatening
conditions.3 In January 2016, AbbVie announced
that the FDA granted priority review for the single agent NDA
application for VENCLEXTA.
In April 2016, U.S. FDA granted
accelerated approval of VENCLEXTA for the treatment of patients
with relapsed/refractory CLL with 17p deletion, as detected by an
FDA-approved test.4 This indication is approved
under accelerated approval based on overall response
rate.4 Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
a confirmatory trial. 4
AbbVie and Genentech are committed to BCL-2 research with
venetoclax, which is currently being evaluated in combination with
other agents in Phase 3 clinical trials for the treatment of
relapsed/refractory and first-line CLL,5 along with
early phase studies in several cancers.4, 6, 7, 8,
9
Venetoclax is under evaluation by health authorities in multiple
countries, and is currently approved in more than 49 nations,
including the U.S.
What is VENCLEXTA™ (venetoclax)?
VENCLEXTA™
(venetoclax) is a prescription medicine used to treat people with
chronic lymphocytic leukemia (CLL) with 17p deletion who have
received at least one prior treatment.
VENCLEXTA was approved based on response rate. There is an
ongoing study to find out how VENCLEXTA works over a longer period
of time.
It is not known if VENCLEXTA is safe and effective in
children.
Important Safety Information
What is the most
important information I should know about VENCLEXTA?
VENCLEXTA can cause serious side effects,
including:
Tumor lysis syndrome (TLS). TLS is caused
by the fast breakdown of cancer cells. TLS can cause kidney
failure, the need for dialysis treatment, and may lead to death.
Your doctor will do tests for TLS. It is important to keep your
appointments for blood tests. You will receive other medicines
before starting and during treatment with VENCLEXTA to help reduce
your risk of TLS. You may also need to receive intravenous (IV)
fluids into your vein. Tell your doctor right away if you have any
symptoms of TLS during treatment with VENCLEXTA, including fever,
chills, nausea, vomiting, confusion, shortness of breath, seizures,
irregular heartbeat, dark or cloudy urine, unusual tiredness, or
muscle or joint pain.
Drink plenty of water when taking VENCLEXTA to help reduce
your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces
total) of water each day, starting 2 days before your first dose,
on the day of your first dose of VENCLEXTA, and each time your dose
is increased.
Who should not take VENCLEXTA?
Certain medicines
must not be taken when you first start taking VENCLEXTA and while
your dose is being slowly increased.
- Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements. VENCLEXTA and other medicines may affect
each other, causing serious side effects.
- Do not start new medicines during treatment with VENCLEXTA
without first talking with your doctor.
What should I tell my doctor before taking
VENCLEXTA?
Before taking VENCLEXTA, tell your doctor
about all of your medical conditions, including if you:
- Have kidney or liver problems.
- Have problems with your body salts or electrolytes, such as
potassium, phosphorus, or calcium
- Have a history of high uric acid levels in your blood or
gout
- Are scheduled to receive a vaccine. You should not receive a
"live vaccine" before, during or after treatment with VENCLEXTA
until your doctor tells you it is okay. If you are not sure about
the type of immunization or vaccine, ask your doctor. These
vaccines may not be safe or may not work as well during treatment
with VENCLEXTA.
- Are pregnant or plan to become pregnant. VENCLEXTA may harm
your unborn baby. If you are able to become pregnant, your doctor
should do a pregnancy test before you start treatment with
VENCLEXTA, and you should use effective birth control during
treatment and for 30 days after the last dose of VENCLEXTA.
- Are breastfeeding or plan to breastfeed. It is not known if
VENCLEXTA passes into your breast milk. Do not breastfeed during
treatment with VENCLEXTA.
What should I avoid while taking VENCLEXTA?
You should
not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or
starfruit while you are taking VENCLEXTA. These products may
increase the amount of VENCLEXTA in your blood.
What are the possible side effects of VENCLEXTA?
VENCLEXTA can cause serious side effects, including:
- Low white blood cell count (neutropenia). Low white
blood cell counts are common with VENCLEXTA, but can also be
severe. Your doctor will do blood tests to check your blood counts
during treatment with VENCLEXTA. Tell your doctor right away if you
have a fever or any signs of an infection.
The most common side effects of VENCLEXTA include low
white blood cell count, diarrhea, nausea, low red blood cell count,
upper respiratory tract infection, low platelet count, and feeling
tired.
VENCLEXTA may cause fertility problems in males. This may affect
your ability to father a child. Talk to your doctor if you have
concerns about fertility.
These are not all the possible side effects of VENCLEXTA. Tell
your doctor if you have any side effect that bothers you or that
does not go away.
The full U.S. prescribing information for VENCLEXTA can be
found here.
Patient Assistance Program
For those who qualify,
AbbVie and Genentech offer patient assistance programs for people
taking Venclexta in the U.S.
About EMPLICITI™ (elotuzumab) in the U.S.
EMPLICITI is
an immunostimulatory antibody that specifically targets Signaling
Lymphocyte Activation Molecule Family member 7 (SLAMF7), a
cell-surface glycoprotein. SLAMF7 is expressed on myeloma cells
independent of cytogenetic abnormalities. SLAMF7 is also expressed
on Natural Killer cells, plasma cells and at lower levels on
specific immune cell subsets of differentiated cells within the
hematopoietic lineage.10
EMPLICITI has a dual mechanism-of-action. It directly activates
the immune system through Natural Killer cells via the SLAMF7
pathway. EMPLICITI also targets SLAMF7 on myeloma cells, tagging
these malignant cells for Natural Killer cell-mediated destruction
via antibody-dependent cellular toxicity.
On November 30, 2015, the U.S.
Food and Drug Administration (FDA) approved EMPLICITI in
combination with lenalidomide and dexamethasone in patients with
multiple myeloma who have received one to three prior therapies.
The safety and efficacy of EMPLICITI is still being evaluated by
other health authorities. Bristol-Myers
Squibb and AbbVie are co-developing EMPLICITI, with
Bristol-Myers Squibb solely responsible for commercial
activities.
EMPLICITI™ (elotuzumab) U.S. IMPORTANT SAFETY
INFORMATION
WHAT IS EMPLICITI?
EMPLICITI™ (elotuzumab) is a prescription medicine used to treat
multiple myeloma in combination with the medicines REVLIMID®
(lenalidomide) and dexamethasone in people who have received one to
three prior treatments for their multiple myeloma.
It is not known if EMPLICITI is safe and effective in
children.
IMPORTANT SAFETY INFORMATION
EMPLICITI is used in combination with REVLIMID and
dexamethasone. It is important to remember that the safety
information for these medications also applies to EMPLICITI
combination therapy.
Before you receive EMPLICITI, tell your healthcare provider
about all of your medical conditions, including if you:
- have an infection
- are pregnant or plan to become pregnant. It is not known if
EMPLICITI may harm your unborn baby. However, REVLIMID may cause
birth defects or death of an unborn baby.
-
- Before receiving EMPLICITI with REVLIMID and dexamethasone,
females and males must agree to the instructions in the REVLIMID
REMS® program. This program has specific requirements about birth
control (contraception), pregnancy testing, blood donation, and
sperm donation that you need to know. Talk to your healthcare
provider to learn more about REVLIMID.
- are breastfeeding or plan to breastfeed. It is not known if
EMPLICITI passes into breast milk. You should not breastfeed during
treatment with EMPLICITI and REVLIMID and dexamethasone.
- Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
Serious side effects that can occur with EMPLICITI treatment
are:
Infusion reactions
- Infusion reactions can happen during your infusion or within 24
hours after your infusion of EMPLICITI. Your healthcare provider
will give you medicines before each infusion of EMPLICITI to help
reduce the risk of an infusion reaction.
- If you have an infusion reaction while receiving EMPLICITI,
your healthcare provider will slow or stop your infusion and treat
your reaction. If you have a severe infusion reaction your
healthcare provider may stop your treatment completely.
- Tell your healthcare provider or get medical help right away if
you have any of these symptoms after your infusion with EMPLICITI:
fever, chills, rash, trouble breathing, dizziness,
light-headedness.
Infections
- Those receiving EMPLICITI with REVLIMID and dexamethasone may
develop infections; some can be serious.
- Tell your healthcare provider right away if you have any of the
signs and symptoms of an infection, including: fever, flu-like
symptoms, cough, shortness of breath, burning with urination, or a
painful skin rash.
Risk of new cancers (malignancies)
- Those receiving EMPLICITI with REVLIMID and dexamethasone have
a risk of developing new cancers.
- Talk with your healthcare provider about your risk of
developing new cancers if you receive EMPLICITI.
- Your healthcare provider will check you for new cancers during
your treatment with EMPLICITI.
Liver problems
- EMPLICITI may cause liver problems. Your healthcare provider
will do blood tests to check your liver during treatment with
EMPLICITI.
- Tell your healthcare provider if you have signs and symptoms of
liver problems, including: tiredness, weakness, loss of appetite,
yellowing of your skin or eyes, color changes in your stools,
confusion, or swelling of the stomach area.
The most common side effects of EMPLICITI include:
- fatigue
- diarrhea
- fever
- constipation
- cough
- numbness, weakness, tingling, or burning pain in your arms or
legs
- sore throat or runny nose
- upper respiratory tract infection
- decreased appetite
- pneumonia
These are not all of the possible side effects of EMPLICITI.
Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.
Please read Patient Information in the full Prescribing
Information.
About ABBV-621
ABBV-621 is a first-in-class,
second-generation TRAIL-receptor agonist under development for the
treatment of solid and hematologic tumors.
About Pharmacyclics, An AbbVie Company
Pharmacyclics
LLC, a wholly-owned subsidiary of AbbVie (NYSE: ABBV), is focused
on developing and commercializing innovative small-molecule drugs
for the treatment of cancer and immune-mediated diseases.
Pharmacyclics' mission is to develop and commercialize novel
therapies intended to improve quality of life, increase duration of
life and resolve serious unmet medical needs.
Pharmacyclics markets IMBRUVICA and has two product candidates
in clinical development and several preclinical molecules in lead
optimization. Pharmacyclics is committed to high standards of
ethics, scientific rigor and operational efficiency as it moves
each of these programs toward commercialization. To learn more,
please visit www.pharmacyclics.com.
About AbbVie in Oncology
At AbbVie, we strive to
discover and develop medicines that deliver transformational
improvements in cancer treatment by uniquely combining our deep
knowledge in core areas of biology with cutting-edge technologies,
and by working together with our partners – scientists, clinical
experts, industry peers, advocates, and patients. We remain focused
on delivering these transformative advances in treatment across
some of the most debilitating and widespread cancers. We are also
committed to exploring solutions to help patients obtain access to
our cancer medicines. With the acquisitions of Pharmacyclics in
2015 and Stemcentrx in 2016, our research and development efforts,
and through collaborations, AbbVie's oncology portfolio now
consists of marketed medicines and a pipeline containing multiple
new molecules being evaluated worldwide in more than 200 clinical
trials and more than 20 different tumor types. For more
information, please visit http://abbvieoncology.com.
About AbbVie
AbbVie is a global, research-driven
biopharmaceutical company committed to developing innovative
advanced therapies for some of the world's most complex and
critical conditions. The company's mission is to use its expertise,
dedicated people and unique approach to innovation to markedly
improve treatments across four primary therapeutic areas:
immunology, oncology, virology and neuroscience. In more than
75 countries, AbbVie employees are working every day to advance
health solutions for people around the world. For more information
about AbbVie, please visit us at www.abbvie.com.
Follow @abbvie on
Twitter, Facebook or LinkedIn.
AbbVie Forward-Looking Statements
Some statements in
this news release may be forward-looking statements for purposes of
the Private Securities Litigation Reform Act of 1995. The words
"believe," "expect," "anticipate," "project" and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements
are subject to risks and uncertainties that may cause actual
results to differ materially from those indicated in the
forward-looking statements. Such risks and uncertainties include,
but are not limited to, challenges to intellectual property,
competition from other products, difficulties inherent in the
research and development process, adverse litigation or government
action, and changes to laws and regulations applicable to our
industry.
Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," in
AbbVie's 2016 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
References
1 IMBRUVICA US Prescribing Information, January 2017.
2 Genetics Home Reference (2017). Isolated growth
hormone deficiency.
http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency.
Accessed November 2017.
3 U.S. Food and Drug Administration. Fact Sheet:
Breakthrough Therapies. Available from:
https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm.
Accessed November 2017
4 VENCLEXTA [Package Insert]. North Chicago, Ill.: AbbVie Inc.
5 Clinicaltrials.gov. NCT02005471: A Study of Venetoclax
in Combination With Rituximab Compared With Bendamustine in
Combination With Rituximab in Participants With Relapsed or
Refractory Chronic Lymphocytic Leukemia. Accessed November 2017.
6 Clinicaltrials.gov. NCT01994837: A Phase 2 Study of
ABT-199 in subjects with Acute Myelogenous Leukemia (AML). Accessed
November 2017.
7 Clinicaltrials.gov. NCT01794520: Study evaluating
ABT-199 in subjects with relapsed or refractory Multiple Myeloma.
Accessed November 2017.
8 Clinicaltrials.gov. NCT01328626: A Phase 1 study
evaluating the safety and pharmacokinetics of ABT-199 in subjects
with relapsed or refractory Chronic Lymphocytic Leukemia and
Non-Hodgkin Lymphoma. Accessed November
2017.
9 Clinicaltrials.gov. NCT01889186: A study of the
efficacy of ABT-199 in subjects with relapsed/refractory or
previously untreated chronic lymphocytic leukemia with the 17p
deletion. Accessed November 2017.
10 Empliciti [Package Insert]. Princeton, N.J.: Bristol-Myers Squibb
Company.
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