Genmab, which is developing the drug with GlaxoSmithKline PLC, said it aims to submit the drug, called ofatumumab, for U.S. and European regulatory approval by the end of this year. ❋ Unknown (2008)
Genmab said it and Glaxo will continue to review the results of the non-Hodgkin's lymphoma study and discuss the development strategy for Arzerra in the treatment of the condition, which is also known as ofatumumab. ❋ Unknown (2009)
"We are committed to the further development of ofatumumab in [non-Hodgkin's lymphoma]," said Genmab Chief Executive Lisa Drakeman. ❋ Unknown (2009)
About 44% of patients in the other group responded well to ofatumumab. ❋ Unknown (2008)
After 24 weeks, 51% of patients in the group not responding to both older medicines experienced a strong response to ofatumumab, Genmab said. ❋ Unknown (2008)
All of the patients were given eight weekly infusions of ofatumumab and then four monthly infusions. ❋ Unknown (2008)
Glaxo is hoping that ofatumumab will boost its presence in the oncology business, which is growing at a faster rate than other disease areas. ❋ Unknown (2008)
We are also evaluating the safety of PCI-32765 in combination with ofatumumab in a Phase IB/II study of patients with relapsed/refractory CLL/SLL.
Genmab A/S announced today plans to begin four studies of ofatumumab in chronic lymphocytic leukemia ... ❋ Editors (2010)
- In July, we announced positive interim data in the ofatumumab Phase II safety and pharmacokinetics study in patients with relapsing-remitting multiple sclerosis (RRMS). ❋ Unknown (2010)
- In August, Genmab announced top-line results from an initial Phase II single arm open label study of ofatumumab to evaluate the treatment of relapsed Diffuse Large B-Cell Lymphoma ❋ Unknown (2010)
Genmab is changing its 2010 financial guidance primarily as a result of the amendment of the ofatumumab co-development and commercialization agreement with GSK. ❋ Unknown (2010)
The U.S. Food and Drug Administration today approved Arzerra (ofatumumab) for patients with chronic ... ❋ Editors (2010)
Genmab's future funding commitment for the development of ofatumumab in oncology indications will be capped at a total of GBP 145 million, including a yearly cash funding cap of GBP 17 million. ❋ Unknown (2010)
FDA approved Arzerra (ofatumumab) in October 2009 for patients whose chemotherapy and Treanda (bendamustine) in March 2008 for patients with CLL who had not received prior treatment. ❋ Editors (2010)
- In August, GSK and Genmab announced top-line results from the concluded pivotal trial of ofatumumab in patients with fludarabine and alemtuzumabrefractory CLL. ❋ Unknown (2010)
Under the terms of the amendment, GSK will take responsibility for developing ofatumumab in autoimmune indications while continuing to jointly develop ofatumumab with Genmab in oncology indications. ❋ Unknown (2010)
"The improvement to the guidance has been driven by the amendment to the ofatumumab co-development and commercialization agreement with GlaxoSmithKline, including the receipt of an upfront payment of GBP 90 million (DKK 815 million), substantially improving the projected cash balance for the end of the year," said Prof. Jan van de Winkel, Ph. D., ❋ Unknown (2010)
- In July, we amended the ofatumumab co-development and commercialization agreement with ❋ Unknown (2010)
