Seattle Genetics' Adcetris (brentuximab vedotin) recieved its second thumbs up from a second FDA advisory panel today -- this time for the treatment of anaplastic large cell lymphoma (ALCL). Once again, the panel voted 10-0 to recommend the drug's approval.
About 2,000 new cases of anaplastic large cell lymphoma are diagnosed each year, half get effectively treated with chemo, but once it recurs, patients are only expected to live a little more than three months. The data for the Seattle Genetics drug in this group of patients was striking. The drug completely or partially shrank tumors in 86 percent of the patients studied in a mid-stage trial (50 of 58). Most of the patients (57 percent) went into complete remissions.
The FDA has a deadline of August 30 to complete its review of the Seattle Genetics application to start marketing the drug for patients with Hodgkin’s and anaplastic large cell lymphoma. If approved, the new drug will be Seattle Genetics’ first marketed product after 14 years in business, and it would the first commercially successful version of an “empowered antibody” -- a completely new type of molecule in the fight against cancer. See Xconomy.
Posted by Bruce Lehr July 14th 2011.