Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the use of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma and relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of Hodgkin lymphoma and ALCL. Seattle Genetics has requested a Priority Review from the FDA that, if granted, provides six months from receipt of the submission for the FDA to take action on the application.
"This BLA submission marks a major milestone in Seattle Genetics' history and brings us one step closer to providing this important new CD30-directed ADC to Hodgkin lymphoma and ALCL patients," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "In our registration trials, nearly all patients with relapsed or refractory Hodgkin lymphoma or systemic ALCL who were treated with brentuximab vedotin had reductions in tumor volume. Importantly, a high percentage of these late-stage patients achieved an objective antitumor response with a substantial portion of durable complete remissions and a manageable safety profile. If approved, brentuximab vedotin would be the first of a new class of ADCs, representing a potentially significant step forward in the way certain types of cancer are treated."
The BLA is based on results from both a pivotal trial in relapsed or refractory Hodgkin lymphoma and a phase II trial in relapsed or refractory systemic ALCL that were presented at the 52nd American Society of Hematology (ASH) Annual Meeting in December 2010.
Results from the pivotal trial in 102 relapsed or refractory Hodgkin lymphoma patients demonstrated that:
- 94 percent of patients had reductions in tumor volume
- 75 percent of patients achieved an objective response, including 34 percent with complete remissions
- The most common adverse events were peripheral sensory neuropathy (47 percent), fatigue (46 percent), nausea (42 percent), upper respiratory tract infection (37 percent) and diarrhea (36 percent)
Results from the phase II trial in 58 relapsed or refractory systemic ALCL patients demonstrated that:
- 97 percent of patients had reductions in tumor volume
- 86 percent of patients achieved an objective response, including 53 percent with complete remissions
- The most common adverse events were nausea (38 percent), peripheral sensory neuropathy (38 percent), fatigue (34 percent), fever (33 percent) and diarrhea (29 percent)
The pivotal trial in Hodgkin lymphoma was conducted under a Special Protocol Assessment (SPA) with the FDA. Brentuximab vedotin has been granted orphan drug designation by the FDA for the treatment of Hodgkin lymphoma and ALCL and has been granted fast track designation by the FDA for Hodgkin lymphoma.