Cue the Trumpets! Seattle Genetics gained FDA approval to market its antibody drug conjugate (ADC) brentuximab vedotin for the treatment of Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL). Yeah!
This is the first ADC to gain approval on the US market and it will be sold under the name Adcetris. The approval came about two weeks ahead of the official review date of August 30th. This is great news for Seattle Genetics as it is the Company's first approved drug after being in business for 14 years and spending nearly $546 M in R&D to reach this point.
The industry has been watching the progress of so-called "empowered antibodies" -- antibodies linked to powerful toxins to target specific cancers -- and a big success here for Seattle Genetics will only embolden other companies in the field. Seattle Genetics also has several more candidates of its own in various stages of the clinical pipeline.
The company didn’t discuss one of the key facts investors will want to know immediately about the new product—its price. Most analysts expect that the drug will end up costing more than $100,000 per patient, as it is given to patients in a series of intravenous infusions once every three weeks. Seattle Genetics said it plans to discuss more of its commercial plans on a conference call with investors at 8:30 am ET/5:30 am PT on Aug. 22. See Xconomy.
Posted by Bruce Lehr Aug 19th 2011.