GSK AND GENMAB RECEIVE ACCELERATED APPROVAL FOR ARZERRA
Philadelphia, PA and Copenhagen, Denmark; October 26, 2009 - Today, GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced the accelerated approval of ArzerraTM (ofatumumab) from the US Food and Drug Administration for use in patients with chronic lymphocytic leukemia (CLL) that is refractory to fludarabine and alemtuzumab.
"The approval of Arzerra brings an important new treatment option to patients with refractory CLL," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "This approval also marks a key milestone for Genmab as it is our first antibody to reach the market. All of us involved in the development of Arzerra are pleased that we have been able to move the product so quickly through research and development and meet our goal of providing this innovative therapy to patients."
The approval is based on results from a pivotal study in which 42% of patients with CLL who were refractory to both fludarabine and alemtuzumab (two therapies used in treating CLL) responded to treatment with Arzerra. These patients had a median duration of response of 6.5 months. The most common adverse reactions (≥10%) seen were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis, and upper respiratory tract infections. The most common serious adverse reactions seen were infections (including pneumonia and sepsis), neutropenia, and pyrexia.
"Arzerra is a significant step forward in helping patients and physicians better manage the challenges of refractory CLL. Patients now have a new choice," said Kathy Rouan, Ph.D., Vice President and Medicines Development Leader at GlaxoSmithKline. "The Arzerra approval demonstrates the commitment of the GSK BioPharm and Oncology Units to developing new biopharmaceutical treatment options for cancer patients."
Arzerra is a monoclonal antibody that causes the body's immune response to fight against normal and cancerous B-cells. Arzerra attaches to the small and large loop epitopes - on a molecule called CD20, which is found on the surface of B-cells, the type of cell which becomes cancerous in CLL.
The approval of Arzerra was supported by a positive recommendation by the FDA's Oncologic Drugs Advisory Committee (ODAC) at ASCO on May 29, 2009, in which the panel voted, 10-3, that the Arzerra data were likely to predict clinical benefit for patients with CLL whose disease is refractory to fludarabine and alemtuzumab.
Arzerra is anticipated to be available for prescription use in the coming weeks.
GSK has added Arzerra to its expanding patient assistance program, Commitment to Access, and has expanded the program. This program assists eligible patients, with or without insurance, with paying for cancer medicines. For more information about the program, visit www.CommitmentToAccess.com or call 1-8ONCOLOGY1 (1-866-265-6491).
Genmab will hold a conference call to discuss today's news on October 27, 2009, at
2:30 pm CEST
1:30 pm BST
9:30 am EDT
The conference call will be held in English.
The dial in numbers are as follows:
+1-877-941-8609 (in the US) and provide conference ID number 4171231
+1-480-629-9818 (outside the US) and provide conference ID number 4171231
To listen to a live webcast of the call please visit www.genmab.com.
The GSK Biopharm R&D Unit seeks to harness the therapeutic potential of biopharmaceuticals for the benefit of patients with debilitating and life threatening disease. We work in tandem with the Oncology R&D Unit, which is dedicated to producing innovations in cancer treatment that will make profound differences in the lives of patients. Through GSK's revolutionary 'bench to bedside' approach, we are transforming the way treatments are discovered and developed, resulting in one of the most robust pipelines in the oncology sector.
GlaxoSmithKline - 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