An experimental drug showing positive results with FDA to review the drug next year:
"Experimental drug Brentuximab Vedotin (SGN-35) achieved tumor volume reductions in 94% of Relapsed or Refractory Hodgkin Lymphoma patients while 34% of them achieved complete remission, Seattle Genetics reported after completing a Pivotal Clinical Trial. The company expects to submit the medication to the FDA (Food and Drug Administration) for approval during the first quarter of 2011 and to European regulators during the first half of 2011.
Brentuximab vedotin is an ADC (antibody-drug conjugate). It targets a defining marker of Hodgkin lymphoma - CD30. Presenters explained the results of the trial at the 52nd American Society of Hematology (ASH) Annual Meeting in Orlando, Florida.
The pivotal trial involving 102 patients with relapsed or refractory Hodgkin lymphoma achieved:
- 75% of patients achieved the primary endpoint of the trial
- Complete remission was acheived in 34% of patients
- Independent central review confirmed a 29 week median response, and 47 weeks by investigator assessment
- Median duration of response among complete remission patients had not been reached at a median 1-year follow-up
- 94% of all patients experienced tumor reductions
The company reports that adverse events were manageable, and included peripheral sensory neuropathy, nausea, diarrhea, upper respiratory tract infection, nausea and fatigue."
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