, 2025-05-01 14:55:00
The European Medicines Agency’s (EMA) committee on human medicines has approved extended indications for two medicines used to treat Hodgkin disease and leukemia, respectively.
In Hodgkin disease, Adcetris (brentuximab vedotin, Takeda Pharma A/S) is currently indicated for adult patients with previously untreated CD30+ stage III or IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine, and dacarbazine. It is also indicated for the treatment of adult patients with relapsed or refractory CD30+ HL after autologous stem cell transplant (ASCT) or those at increased risk of relapse or progression after ASCT or at least two prior therapies when ASCT or multi ‑ agent chemotherapy is not a treatment option.
The committee recommended approval for an application to expand this to include treatment of adults with previously untreated CD30+ stage IIB with risk factors, stage III, or stage IV HL, in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone (BrECADD).
The drug is an antibody-drug conjugate comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E. It is also currently indicated for various forms of systemic anaplastic large cell lymphoma and cutaneous T ‑ cell lymphoma.
Extension of the indications in HL was based on the results of a randomized phase 3 trial, HD21, under the auspices of the German Hodgkin Study Group, which showed that BrECADD was better tolerated and more effective than the current standard of care regimen predominantly used in Europe in first-line treatment of adult patients with newly diagnosed advanced-stage (IIb/III/IV) classical HL.
Extension of Indications for CLL Drug
The committee also recommended extending the marketing authorizations for Calquence (acalabrutinib maleate, AstraZeneca), currently indicated as monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). As a result of the decision, it will now be indicated in combination with venetoclax, with or without obinutuzumab, for the same patient group. Current indications also include adult CLL patients who have received at least one prior therapy.
CLL is the most common type of leukemia in adults, with an estimated 27,000 patients diagnosed in the UK, France, Germany, Spain, and Italy in 2024.
The recommendation was based on the AMPLIFY phase III trial, which showed that fixed-duration acalabrutinib-venetoclax (with or without obinutuzumab) yielded statistically significant and clinically meaningful improvements in progression-free survival compared with chemoimmunotherapy in untreated CLL. Estimated 36-month progression-free survival was 76.5% with acalabrutinib-venetoclax and 83.1% with acalabrutinib-venetoclax-obinutuzumab, vs 66.5% with chemoimmunotherapy.
Estimated 36-month overall survival on the two and three drug combinations was 94.1% and 87.7%, respectively, vs 85.9% with chemoimmunotherapy. Acalabrutinib is under additional monitoring to enhance reporting of suspected adverse drug reactions, but no new safety signals were identified during the trial.
Detailed recommendations for the use of both products in their expanded indications will be described in the updated summary of product characteristics, which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorization has been granted by the European Commission.
