Takeda has received a new recommendation from the European Medicines Agency’s human medicines committee for its Pfizer-partnered blood cancer drug Adcetris (brentuximab vedotin).
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the CD30-directed antibody-drug conjugate (ADC) be approved alongside etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) to treat newly diagnosed stage IIb Hodgkin lymphoma (HL) in adults with risk factors/III/IV.
The CHMP’s positive opinion was supported by results from the late-stage HD21 trial evaluating Adcetris plus ECADD against escalated doses of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone, a standard of care in Europe.
The study met its co-primary endpoints, with the Adcetris regimen demonstrating significantly improved safety as assessed by treatment-related morbidity and non-inferior progression-free survival.
HL is a relatively aggressive cancer that originates in the lymphatic system. It is distinguished from other types of lymphoma by the presence of Reed-Sternberg cells, which typically carry the CD30 protein on their surface.
Adcetris, which is already approved in Europe for six indications, belongs to a class of cancer drugs that combine the selectivity of antibodies with the cell-killing properties of chemotherapy or other anti-cancer agents. Unlike chemotherapy, which works by attacking lots of different cells as well as the cancer, ADCs are designed to target and kill tumour cells while sparing healthy ones.
The European Commission will now review the CHMP’s recommendation as it makes a decision on Adcetris in this indication.
Takeda is responsible for Adcetris’ commercialisation everywhere except the US and Canada, where Pfizer holds commercialisation rights.
The latest announcement for Adcetris comes less than a month after the National Institute for Health and Care Excellence (NICE) recommended in final draft guidance that Adcetris be used on the NHS alongside doxorubicin, vinblastine and dacarbazine to treat patients with untreated stage 3 or 4 CD30-positive HL.
The decision made Adcetris the first drug to be recommended specifically for previously untreated late-stage classical HL and followed an “improved confidential discount” on the treatment’s list price offered by Takeda, NICE said.