Seattle Genetics has its review date with the FDA set for July 14th to get an Advisory Committee decision on its antibody drug conjugate (ADC) brentuximab vedotin (SGN-35). BLA's for the drug's use in the treatment of Hodgkin's and anaplastic large cell lymphoma will both be reviewed in back to back sessions.
SGN-35 remains on pace to be the first ADC approved. And if the committe recommendation is positive as widely expected, Seattle Genetics will be really have something to celebrate (besides Bastille Day) as it moves to storm the market.
Posted by Bruce Lehr June 16th 2011.
Hello: The SGN35 has been suggested for my son to receive for his relapsed HL following his autologous stem cell transplant at DUKE. He just completed in January, 2011 and his HL is back. His physician did say it would probably be 12 to 13 weeks before it could be available...maybe even longer. I had been searching online and then later sent an email to Seattle Genetics. Northside in Atlanta, GA has an open-label expanded access trial presently and they are accepting patients. My son's records are being mailed to them now. Hopefully, he will be accepted and this treatment can be started earlier than his physician at DUKE could start. Cust Rep at Seattle Genetics would be able to let you know of the places closest to your daughter-in-law that would be currently having these clinical trials. Sure hope she will be well. My son was initially diagnosed in 2008 and following chemo and radiation, it returned. He later had another round of chemo and then most recently, had high dose chemo at DUKE prior to receiving the stem-cell transplant.
Posted by: Faye | 07/09/2011 at 02:36 PM
It is widely expected that the FDA will approve this drug. Hopefully, it can help your daughter-in-law in her fight.
Posted by: bigredbruce | 07/06/2011 at 03:27 PM
I hope the FDA does not drag its feet on this one!! My daughter-in-law has tried everything for her Hodgkins Lymphoma for the last eight years, even autologous stem-cell transplant and most recently RAD001. We don't want to lose her, but time is running out as are our finances.
Our last hope may be that Dr. Younes at MDA gets her on the list for treatment or clinical trial!!!
Posted by: J. Stephen Williams | 07/06/2011 at 03:11 PM