(This press release should have contained a quote from SGEN management as to the expected and predicted nature of this development...but it does not.)
-- Seattle Genetics Announces FDA Advisory Committee to Review Brentuximab Vedotin for the Treatment of Relapsed or Refractory Hodgkin Lymphoma and Systemic ALCL Oncologic Drugs Advisory Committee Meetings Scheduled for July 14, 2011
BOTHELL, Wash., Jun 16, 2011 (BUSINESS WIRE) --
Seattle Genetics, Inc. (Nasdaq: SGEN) today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the company's Biologics License Applications (BLAs) for brentuximab vedotin (ADCETRIS(TM)) on July 14, 2011. ODAC plans to review the BLA for the treatment of relapsed or refractory Hodgkin lymphoma during the morning session and the BLA for the treatment of relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) during the afternoon session. Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of Hodgkin lymphoma and ALCL.
ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes appropriate recommendations to the FDA. The FDA regulations indicate that although the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made by the FDA solely, and the recommendations by the panel are non-binding.
Seattle Genetics announced on May 2, 2011 that the FDA had accepted for filing two BLAs for brentuximab vedotin, including one for the treatment of relapsed or refractory Hodgkin lymphoma and one for the treatment of relapsed or refractory systemic ALCL. The FDA has granted a six-month priority review of both applications, and has established an action date of August 30, 2011 under the Prescription Drug User Fee Act (PDUFA). The BLAs for brentuximab vedotin are based on results from both a pivotal trial in relapsed or refractory Hodgkin lymphoma and a phase II trial in relapsed or refractory systemic ALCL. The pivotal trial in Hodgkin lymphoma was conducted under a Special Protocol Assessment (SPA) with the FDA. Brentuximab vedotin has been granted orphan drug designation by the FDA for the treatment of Hodgkin lymphoma and ALCL.
This, too, shall pass, but the current decline in SGEN's pps is largely related, imo, to the company's failure to add a sentence or two of context and perspective to today's ODAC press release.
"This is an expected part of the process. We have been preparing for our presentations to the ODACs and we look forward to those events." Something as simple, accurate and appropriate as that.
IMO, the greatest risk to our investment in Seattle Genetics is not its science, not its products, not its eventual marketing operation. The greatest risk to our investment is the media/public relations department's frequent failure to do its job professionally and properly.