Seattle Genetics announced that the Food and Drug Administration (FDA) has accepted a supplemental Biologic License Application (sBLA) and granted Priority Review designation for Adcetris (brentuximab vedotin) in cutaneous T-cell lymphoma (CTCL).
The sBLA submission was based on positive results from the Phase 3 ALCANZA trial and two Phase 2 investigator-sponsored trials of Adcetris in patients with CTCL. Objective response lasting at least 4 months (ORR4) served as the primary endpoint. The data showed a higher percentage of patients treated with Adcetris achieved ORR4 vs. patients treated with control (56.3% vs. 12.5%; P<0.0001). Key secondary endpoints included complete response rate, progression-free survival (PFS), and reduction in the burden of symptoms during treatment. All secondary endpoints were highly statistically significant in favor of Adcetris.
Adcetris is an antibody-drug conjugate (ADC) directed against CD30, which is expressed in classical Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). The anticancer activity of Adcetris is due to binding of the ADC to CD30-expressing cells, followed by internalization of the ADC-CD30 complex and the release of MMAE, a microtubule disrupting agent, via proteolytic cleavage.
Adcetris is already indicated for the treatment of classical HL patients who fail autologous hematopoietic stem cell transplantation (auto-HSCT) or who fail at least two prior multi-agent chemotherapy regimens and are not auto-HSCT candidates. It is also indicated for the treatment of sALCL patients who fail at least one prior multi-agent chemotherapy regimen.
Adcetris is available as a 50mg strength lyophilized cake or powder in single-use vials. Seattle Genetics expects the FDA to make a decision on the sBLA by its Prescription Drug User Fee Act (PDUFA) date of December 16, 2017.
For more information call (855) 473-2436 or visit Adcetris.com.