brentuximab vedotin (Adcetris)

following a full submission assessed under the ultra-orphan process.

brentuximab vedotin (Adcetris®) is accepted for restricted use within NHS Scotland.

Indication under review: treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):
1. following autologous stem cell transplant (ASCT) or
2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment   option  and
treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
 
SMC restriction: treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):
1. following autologous stem cell transplant (ASCT) or
2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option

In an open-label, single-arm study, patients with relapsed or refractory Hodgkin lymphoma treated with brentuximab vedotin achieved an objective response rate of 75%.  Controlled data with clinical outcomes are currently lacking.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

Brentuximab is also indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). SMC cannot recommend use in sALCL as the company did did not include evidence for use in this indication in its submission.