Seattle Genetics turned in its FDA application for its antibody drug conjugate or "empowered antibody" known as SGN-35 or brentuximab vedotin for the treatment of Hodgkin's disease.
SeaGen Turns in FDA Application.
It asked the FDA for expedited review - faster than the agency's usual six-month review period for such a treatment. It remains to be seen whether the agency will grant the expedited request. SGN-35 would be Seattle Genetics first product on the market and it would be one of the first if not the first ADC to be approved if the expedited review is granted.
This one will be closely watched as the industry as a whole is expected to make more efforts with empowered anitibodies if SGN-35 and/or Genentech's T-DM1 gain agency approval.
Posted by Bruce Lehr March 2nd 2011.
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