What Adcetris is?
ADCETRIS is a CD30-directed antibody-drug conjugate indicated for treatment of patients with:
- 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.
- Systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen.
Accelerated approval was granted for the above indications based on overall response rate. An improvement in patient-reported outcomes or survival has not been established. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials
What brentuximab vedotin is?
- Brentuximab vedotin (INN, trade name Adcetris) is an antibody-drug conjugate medication used to treat relapsed or refractory Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL). It selectively targets tumor cells expressing the CD30 antigen, a defining marker of Hodgkin lymphoma and ALCL (a type of T cell non-Hodgkin lymphoma).
- In August 2011, the U.S. FDA granted accelerated approval to the biologics license application (BLA) submitted by Seattle Genetics for the use of brentuximab vedotin in the treatment of relapsed HL and ALCL. In March 2018, the FDA granted an expansion of use to include first-line treatment of stage III and IV HL in combination with chemotherapy.
- In October 2012, the European Medicines Agency (EMA) gave it conditional marketing authorization for relapsed or refractory HL and ALCL.
- In November 2017, the FDA approved brentuximab vedotin as a treatment for patients with cutaneous T-cell lymphoma (CTCL) who have received prior systemic therapy. This approval is for patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF).