Seattle Genetics (NSDQ:SGEN) said today that the FDA granted Breakthrough Therapy Designation to its antibody-drug conjugate Adcetris in combination with chemotherapy for treating patients with advanced classical Hodgkin lymphoma.
The approval was based on positive top line results from the company’s phase 3 Echelon-1 clinical trial, which were announced in June.
The Bothell, Wash.-based company said it plans to present full data from the trial at the upcoming American Society of Hematology annual meeting in December.
“The phase 3 Echelon-1 study that supports the Breakthrough Therapy Designation for Adcetris in combination with chemotherapy showed superior activity versus the standard of care chemotherapy regimen in the treatment of frontline advanced classical Hodgkin lymphoma patients. The decision by the FDA to grant this designation recognizes the need for new options that can change the care of people with newly diagnosed advanced Hodgkin lymphoma. The designation supports our goal to make Adcetris available to patients in this setting as soon as possible. We look forward to presenting the data from our phase 3 Echelon-1 trial at the upcoming ASH annual meeting and intend to submit a supplemental Biologics License Application to the FDA before the end of 2017,” prez & CEO Clay Siegall said in a press release.
Seattle Genetics said tis Adcetris is currently being evaluated as the foundation of care for CD30-expressing lymphomas in more than 70 clinical trials, but is currently not approved as a frontline therapy for Hodgkin lymphoma.
In February, Immunomedics (NSDQ:IMMU) said it landed an exclusive global licensing agreement with Seattle Genetics for Immunomedics’ antibody-drug conjugate, IMMU-132, for the treatment of solid tumors. The deal could potentially bring in $2 billion plus royalties for Immunomedics.
