(1888PressRelease)
May 30, 2009 - "The committee's positive vote in support of ofatumumab is a potential milestone for patients with CLL. While current initial treatments for CLL can provide prolonged remissions, some patients will progress rapidly and relapse, which highlights the need for new therapies,” said Debasish Roychowdhury, M.D., Senior Vice President and Head, Medicines Development, GlaxoSmithKline Oncology. “We look forward to working with the FDA towards an approval for ofatumumab.”
CLL is the most common form of adult leukemia in the Western world, and the treatment of patients with relapsed disease remains a significant challenge. Patients who have not responded to current standard therapies, or whose disease has returned following prior treatments, typically experience poorer clinical outcomes such as infections and death. Less than 25 percent of CLL patients who are resistant to current treatments respond to available therapies.
“The positive vote by ODAC confirms that ofatumumab may offer a new treatment option for patients who have received prior therapies with this type of CLL," saidLisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “Today’s vote is positive affirmation for this medicine, which is a result of years of dedicated research and collaboration between Genmab and GSK.”
The advisory committee made its decision based on an interim analysis of a pivotal trial that was presented at the American Society of Hematology 2008 annual meeting and will be presented at the American Society of Clinical Oncology 2009 annual meeting.
"The committee's positive vote in support of ofatumumab is a potential milestone for patients with CLL. While current initial treatments for CLL can provide prolonged remissions, some patients will progress rapidly and relapse, which highlights the need for new therapies,” said Debasish Roychowdhury, M.D., Senior Vice President and Head, Medicines Development, GlaxoSmithKline Oncology. “We look forward to working with the FDA towards an approval for ofatumumab.”
CLL is the most common form of adult leukemia in the Western world, and the treatment of patients with relapsed disease remains a significant challenge. Patients who have not responded to current standard therapies, or whose disease has returned following prior treatments, typically experience poorer clinical outcomes such as infections and death. Less than 25 percent of CLL patients who are resistant to current treatments respond to available therapies.
“The positive vote by ODAC confirms that ofatumumab may offer a new treatment option for patients who have received prior therapies with this type of CLL," saidLisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “Today’s vote is positive affirmation for this medicine, which is a result of years of dedicated research and collaboration between Genmab and GSK.”
The advisory committee made its decision based on an interim analysis of a pivotal trial that was presented at the American Society of Hematology 2008 annual meeting and will be presented at the American Society of Clinical Oncology 2009 annual meeting.
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