Monoclonal Antibodies
Recruitment Completed in Ofatumumab NHL Pivotal Study
Published in Drug Law Weekly, October 7th, 2008
Genmab A/S (OMX: GEN) announced it has completed recruitment of patients in the pivotal Phase III study of ofatumumab (HuMax-CD20(R)) in rituximab refractory follicular non-Hodgkin's lymphoma (NHL). Eighty-one patients receiving treatment at the 1000 mg dose level of ofatumumab have been recruited in the study. Data from these patients will be included in the primary efficacy analysis. An additional 31 patients were recruited at a 500 mg dose level prior to amending the study design to include only one dose. Data from these patients will be evaluated for safety and supportive efficacy analysis.
"We have now recruited the last patient into the study and keenly await the...
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Source: Drug Law Weekly (2008-10-07)
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