Adcetris
Opinion
On 14 September 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Adcetris. The marketing authorisation holder for this medicinal product is Takeda Pharma A/S.
The CHMP adopted an extension to an existing indication to include treatment of Stage III Hodgkin lymphoma (HL). For information, the full indications for Adcetris will be as follows:1
Hodgkin lymphoma
ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD) (see sections 4.2 and 5.1).
ADCETRIS is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT) (see section 5.1).
ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):
- following ASCT, or
- following at least two prior therapies when ASCT or multi‑agent chemotherapy is not a treatment option.
Systemic anaplastic large cell lymphoma
ADCETRIS in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) (see section 5.1).
ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory sALCL.
Cutaneous T‑cell lymphoma
ADCETRIS is indicated for the treatment of adult patients with CD30+ cutaneous T‑cell lymphoma (CTCL) after at least 1 prior systemic therapy (see section 5.1).
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
1New text in bold
Key facts
| Name |
Adcetris |
| Agency product number |
EMEA/H/C/002455 |
| International non-proprietary name (INN) or common name |
|
| Active substance |
|
| Therapeutic area |
Lymphoma, Non-Hodgkin
Hodgkin Disease
|
| Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
| Date opinion adopted |
14/09/2023 |
| Company name | |
| Status |
Positive |
| Application type |
Post-authorisation |