FDA-Approved Adcetris for Lymphoma Patients

In order to approve the drug, the FDA considered data from a phase 3 ALCANZA clinical trial sponsored by Takeda. The goal of the trial was to see a positive response in patients that lasted up to four months. In order to measure the outcomes of the patients receiving Adcetris against a control, half of the trial group was given a standard treatment therapy of their prescribing doctor’s choice. This included the drug methotrexate, commonly used in chemotherapy rounds, and bexarotene.

131 people participated in the international trial, which was open to anyone over the age of 18 with MF or pcALCL. Some exclusions were made based on the levels of CD30+ in a person’s system, whether or not they had another systemic disease that would complication the results of taking the medicine, and whether or not they were receiving medication that would place them at risk during the clinical trial. Participants volunteered from the US and UK, as well as from Australia, Brazil, and most European countries.