rior multi-agent chemotherapy regimens in patients who are not ASCT candidates. Adcetris is also indicated for the treatment of systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen.
Supplemental FDA Application for Lymphoma Drug Adcetris
Seattle Genetics announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA supporting the use of Adcetris (brentuximab vedotin) for the retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL).
The sBLA submission is based on results from a Phase 2 clinical trial with two treatment arms. One arm eva luated retreatment with Adcetris in patients who previously responded to treatment with Adcetris, then discontinued treatment leading to disease progression or relapse. The other arm allowed treatment extension and eva luated prolonged treatment with Adcetris beyond 16 cycles of therapy. The sBLA submission includes updated data sets from this Phase 2 trial.
Adcetris is a CD30-directed antibody-drug conjugate already indicated for the treatment of Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates. Adcetris is also indicated for the treatment of systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen.
Adcetris Under Review for Retreatment and Extended Duration Therapy
Seattle Genetics announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for filing for the use of Adcetris (brentuximab vedotin) for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). Adcetris is an antibody-drug conjugate (ADC) directed to CD30, a marker of HL and sALCL.
The sBLA submission is based on results from a Phase 2 clinical trial with two treatment arms. One arm eva luated retreatment with Adcetris in patients who previously responded to treatment with Adcetris, then discontinued treatment and subsequently had disease progression or relapse. The other arm eva luated extended treatment with Adcetris beyond 16 cycles of therapy. In the retreatment group, of the 23 eva luable patients who were retreated with Adcetris, 70% (16 of 23) achieved an objective response, including complete remissions and seven partial remissions. Median duration of retreatment objective response was 8.8 months. In the extended duration of treatment group, the overall objective response rate with extended treatment was 88%, including 76% complete remissions and 12% partial responses.
In August 2011, Adcetris was granted accelerated approval by the FDA for relapsed HL and relapsed sALCL. It is not currently approved for retreatment and extended duration beyond 16 cycles of therapy in relapsed HL and sALCL.
FDA Grants Orphan Drug Status to Adcetris for Mycosis Fungoides
Seattle Genetics announced that Adcetris (brentuximab vedotin) has been granted orphan drug designation by the FDA for the treatment of mycosis fungoides (MF), the most common type of cutaneous T-cell lymphoma (CTCL). Adcetris (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethy |
