Approval for an investigational drug to treat Hodgkin’s lymphoma in patients who have already had a stem cell transplant was unanimously approved on Thursday by an FDA advisory panel.
As per the details of the arrangement, the drug will be utilized for patients with relapsed or resistant systematic anaplastic large cell lymphoma.
An FDA advisory panel voted unanimously Thursday to recommend accelerated approval for an investigational drug to treat Hodgkin lymphoma in patients who have already had a stem cell transplant, and for patients with relapsed or resistant systemic anaplastic large cell lymphoma. Brentuximab vedotin, which Seattle Genetics has already said it will market as Adcetris, is the combination of antibody and chemotherapy drug to effectively treat rare blood cancer. While the antibody binds the CD30-positive Reed-Sternberg cells, the monomethyl auristatin attacks the internal structure of the cells.
The FDA panel in question, the Oncologic Drugs Advisory Committee, voted it through with a 10-0 total. Much of the approval was based on the very successful trial that the company presented, during which three-quarters of the patients treated had at least a mild reduction in tumor burden while more than a third had an entire remission.
Considering the fact that no new agents have been approved for the treatment of Hodgkin’s lymphoma since the late 1970s, this could be a potentially monumental first step on the road to getting a proper lymphoma treatment on the market.
