Copenhagen, Denmark; May 23, 2014 – GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: 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™ 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:
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® 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 syndrome1
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/mm3), 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 supportive care.
Progressive multifocal leukoencephalopathy1
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.
Hepatitis B 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 34.8 mg sodium per 300 mg dose, 116 mg sodium per 1,000 mg dose and 232 mg sodium per 2,000 mg 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® (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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Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; the DuoBody™ logo; the Hexabody logo™; HuMax®; HuMax-CD20®; DuoBody®, HexaBodyTM and UniBody®.
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1 GlaxoSmithKline. DRAFT ARZERRA Summary of Product Characteristics 2014.
2 GlaxoSmithKline Clinical Study Register. Study OMB110911. http://www.gsk-clinicalstudyregister.com/study/OMB110911?study_ids=OMB110911#ps. Accessed 19 May 2014.
3 GlaxoSmithKline Clinical Study Register. Study 115991 http://www.gsk-clinicalstudyregister.com/study/115991?study_ids=omb115991#ps. Accessed 19 May 2014.
4 European Commission. The Centralised Procedure. http://ec.europa.eu/health/authorisation-procedures-centralised_en.htm. Accessed 14 May 2014.