GSK and Genmab Receive CHMP Positive Opinion for Arzerra(tm) in Combination
with Chlorambucil or Bendamustine as a First-line Treatment for Patients with
Chronic Lymphocytic Leukemia (CLL) Who Are Not Eligible for Fludarabine-based
*CHMP recommends marketing authorization for Arzerra in combination with
chlorambucil or bendamustine for patients with CLL who have not received
prior therapy and are not eligible for fludarabine-based therapy
*Final decision from European Commission expected in the coming months
COPENHAGEN, Denmark, May 23, 2014 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc
(LSE:GSK) and Genmab A/S (Copenhagen:GEN) announced today that the Committee
for Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has issued a positive opinion recommending a variation to the terms of
the marketing authorization for Arzerra(tm) for a new indication in
combination with chlorambucil or bendamustine for the treatment of patients
with chronic lymphocytic leukemia (CLL) who have not received prior therapy
and who are not eligible for fludarabine-based therapy.^1
"This CHMP opinion for Arzerra in the first-line setting brings GSK one step
closer to offering a new treatment option for patients with previously
untreated CLL in Europe," said Dr Rafael Amado, Head of Oncology R&D at GSK.
"We are pleased to receive the positive opinion from the CHMP for Arzerra in
combination with chlorambucil or bendamustine for first line CLL and look
forward to a final decision from the European Commission in the next few
months," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
The CHMP recommendation of the first-line indication is based on results from
two trials in patients with previously untreated CLL considered inappropriate
for a fludarabine-based treatment:
*Phase III OMB110911 study (COMPLEMENT 1), a randomised, open-label,
parallel-arm, multicentre, pivotal Phase III study evaluating the
combination of ofatumumab and chlorambucil (N=221) versus chlorambucil
*Phase II OMB115991, a single-arm, multicentre study that evaluated the
efficacy of ofatumumab in combination with bendamustine (N= 44)^3
A CHMP positive opinion is one of the final steps before marketing
authorisation is granted by the European Commission (EC),^4 but does not
always result in marketing authorization. A final decision by the EC is
anticipated during the third quarter of 2014.
About Arzerra (ofatumumab)
Arzerra (ofatumumab) is a monoclonal antibody that is designed to target the
CD20 molecule found on the surface of CLL cells and normal B lymphocytes.^1
In the US, Arzerra^(r) is approved (April 2014) for use in combination with
chlorambucil for the treatment of previously untreated patients with CLL for
whom fludarabine-based therapy is considered inappropriate. For full US
prescribing information, including Boxed Warning, please see
https://www.gsksource.com/gskprm/htdocs/documents/ARZERRA.PDF. Arzerra is also
approved for first-line use in Russia.
In more than 50 countries worldwide, Arzerra is indicated as monotherapy for
the treatment of patients with CLL refractory to fludarabine and alemtuzumab.
Arzerra is being developed under a co-development and collaboration agreement
between Genmab and GSK.
Arzerra is a registered trademark of the GSK group of companies.
Safety information for Arzerra (ofatumumab)
Please consult the full Summary of Product Characteristics for all the
labelled safety information for Arzerra.
Hypersensitivity to ofatumumab or to any of the excipients.^1
Special warnings and precautions for use of ofatumumab include:
Ofatumumab has been associated with infusion reactions leading to temporary
interruption of treatment or withdrawal of treatment. Infusion reactions may
include anaphylactoid events, cardiac events, chills/rigors, cough, cytokine
release syndrome, diarrhoea, dyspnoea, fatigue, flushing, hypertension,
hypotension, nausea, pain, pyrexia, rash, and urticaria. Infusion reactions
occur more frequently on the first day of infusion and tend to decrease with
subsequent infusions. Patients with a history of decreased pulmonary function
may be at a greater risk for pulmonary complications from severe reactions.
Tumour lysis syndrome^1
In patients with CLL, tumour lysis syndrome (TLS) may occur with use of
ofatumumab. Risk factors for TLS include a high tumour burden, high
concentrations of circulating cells (>= 25,000/mm^3), hypovolaemia, renal
insufficiency, elevated pre-treatment uric acid levels and elevated lactate
dehydrogenase levels. Management of TLS includes correction of electrolyte
abnormalities, monitoring of renal function, maintenance of fluid balance and
Progressive multifocal leukoencephalopathy^1
Progressive multifocal leukoencephalopathy (PML) and death has been reported
in CLL patients receiving cytotoxic pharmacotherapy, including ofatumumab. If
a diagnosis of PML is suspected Arzerra should be discontinued and referral to
a neurologist should be considered.
The safety of, and ability to generate a primary or anamnestic response to,
immunisation with live attenuated or inactivated vaccines during treatment
with ofatumumab has not been studied.
HepatitisB virus (HBV) infection and reactivation, in some cases resulting in
fulminant hepatitis, hepatic failure and death, has occurred in patients
treated with drugs classified as CD20-directed cytolytic antibodies, including
Arzerra. All patients should be screened for HBV infection before initiation
of Arzerra treatment, patients previously exposed to HBV should be followed
closely in consultation with an expert in this disease. Patients with
evidence of prior HBV infection should be monitored for clinical and
laboratory signs of hepatitis or HBV reactivation.
Patients with a history of cardiac disease should be monitored closely.
Arzerra should be discontinued in patients who experience serious or
life-threatening cardiac arrhythmias.
The effect of multiple doses of Arzerra on the QTc interval was evaluated in a
pooled analysis of three open-label studies in patients with CLL (N = 85).
Increases above 5 msec were observed in the median/mean QT/QTc intervals in
the pooled analysis. No large changes in the mean QTc interval (i.e., >20
milliseconds) were detected.
Bowel obstruction has been reported in patients receiving anti-CD20 monoclonal
antibody therapy, including ofatumumab. Patients who present with abdominal
pain, especially early in the course of ofatumumab therapy, should be
evaluated and appropriate treatment instituted.
Cytopenias, including prolonged and late-onset neutropenia, have been reported
during ofatumumab therapy. Complete blood counts, including neutrophil and
platelet counts should be obtained at regular intervals during ofatumumab
therapy and more frequently in patients who develop cytopenias.
This medicinal product contains 34.8mg sodium per 300mg dose, 116mg sodium
per 1,000mg dose and 232mg sodium per 2,000mg dose.This should be taken
into consideration by patients on a controlled sodium diet.
The most common undesirable effects for ofatumumab include adverse events
associated with infusion reactions, cytopenias (neutropenia, anemia, febrile
neutropenia, thrombocytopenia, leucopenia) and infections (lower respiratory
tract infection, including pneumonia, upper respiratory tract infection,
sepsis, including neutropenic sepsis and septic shock, herpes virus infection,
urinary tract infection). ^ 1
GSK- one of the world's leading research-based pharmaceutical and healthcare
companies - is committed to improving the quality of human life by enabling
people to do more, feel better and live longer. For further information
please visit www.gsk.com.
About Genmab A/S
Genmab is a publicly traded, international biotechnology company specializing
in the creation and development of differentiated human antibody therapeutics
for the treatment of cancer. Founded in 1999, the company currently has one
marketed antibody, Arzerra^(r) (ofatumumab) for the treatment of certain
chronic lymphocytic leukemia indications, a clinical pipeline with both late
and early stage programs, and an innovative preclinical pipeline. Genmab's
technology base consists of validated and proprietary next generation antibody
technologies - the DuoBody platform for generation of bispecific antibodies,
and the HexaBody platform which creates effector function enhanced
antibodies. Genmab's deep antibody expertise is expected to provide a stream
of future product candidates. Partnering of selected innovative product
candidates and technologies is a key focus of Genmab's strategy and the
company has alliances with top tier pharmaceutical and biotechnology
companies. For more information visit www.genmab.com.
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"believe", "expect", "anticipate", "intend" and "plan" and similar expressions
identify forward looking statements. Actual results or performance may differ
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Genmab A/S and its subsidiaries own the following trademarks: Genmab^(r); the
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HuMax^(r); HuMax-CD20^(r); DuoBody^(r), HexaBody^TM and UniBody^(r).
Cautionary statement regarding forward-looking statements
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^1 GlaxoSmithKline. DRAFT ARZERRA Summary of Product Characteristics 2014.
^2 GlaxoSmithKline Clinical Study Register. Study OMB110911.
Accessed 19 May 2014.
^3 GlaxoSmithKline Clinical Study Register. Study 115991
Accessed 19 May 2014.
^4 European Commission. The Centralised Procedure.
Accessed 14 May 2014.
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