Seattle Genetics, Inc announced on Monday that the FDA has accepted filings for two Biologics License Applications (BLAs) for bretuximab vedotin. Seattle Genetics submitted a BLA filing for bretuximab vedotin based on results from two recent trials that were presented at the American Society of Hematology meeting in December 2010. Although originally submitted as one, the FDA will review two separate filings of bretuximab vedotin, one for treating patients with relapsed or refractory Hodgkin lymphoma; the other for treating relapsed or refractory systematic anaplastic large cell lymphoma (ALCL).
The FDA has also granted a 6-month priority review of both applications and has established an action date of August 30, 2011. Priority review is typically reserved for drugs that, if approved, would address an otherwise unmet need for life-threatening conditions.
“These filings and priority review designations are an important step forward in our effort to bring brentuximab vedotin to the many relapsed and refractory Hodgkin lymphoma and systemic ALCL patients in need,” said Clay B. Siegall, PhD, President and Chief Executive Officer of Seattle Genetics, in a press release. “We look forward to continued interactions with the FDA as they review our brentuximab vedotin BLAs.”
Bretuximab vedotin, an anti-drug conjugate comprising an anti-CD30 monoclonal antibody, a defining marker of both Hodgkin lymphoma and ALCL. The drug works by targeting specific cells and leaving non-targeted cells unharmed. The mechanism of action is intended to minimize the potential toxic effects of traditional chemotherapy while allowing for the selective targeting of CD30-expressing cancer cells, thus potentially enhancing the antitumor activity.