NEW YORK – Takeda said on Tuesday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion and recommended approval for brentuximab vedotin (Adcetris) in combination with cyclophosphamide, doxorubicin, and prednisone for adults with previously untreated CD30-positive anaplastic large cell lymphoma, or sALCL.
The European Commission will now consider whether to grant marketing authorization to the drug regimen.
Brentuximab vedotin, jointly developed by Seattle Genetics and Takeda, is an antibody-drug conjugate designed to target the cell membrane protein CD30, expressed in sALCL and several other types of peripheral T-cell lymphoma, or PTCL.
The indication is already approved in the United States. In November 2018, the US Food and Drug Administration used its Real-Time Oncology Review Pilot Program do grant approval to brentuximab vedotin in combination with the same chemotherapy regimen as a frontline treatment for adult patients with sALCL or other CD30-expressing peripheral T-cell lymphomas.
But in Europe the treatment has not been approved. The positive CHMP opinion is a step toward making the treatment available for sALCL European patients, Christopher Arendt, head of the Oncology Therapeutic Area Unit at Takeda, said in a statement.
The CHMP recommendation comes in the wake of the multi-center Phase III ECHELON-2 study, which compared the brentuximab vedotin and chemotherapy combination with the standard of care for patients with CD30-positive PTCL. The standard of care regimen is a combination of cyclophosphamide, doxorubicin, vincristine, and prednisone.
The results showed a statistically significant 29 percent improvement in progression-free survival, the primary endpoint of the study. The majority of the patients enrolled in the trial had sACLC. ECHELON-2 also showed that brentuximab vedotin together with the cyclophosphamide, doxorubicin, and prednisone regimen had a similar safety profile to the standard of care chemo regimen.
“If approved for adult patients with previously untreated sALCL, Adcetris may offer an important option for European patients,” Eva Domingo-Domenech of the Institut Catala d’Oncologia – Hospitalet Hospital Duran j Reynals said in a statement. Domingo-Domenech pointed out that, over the past few decades, there have been few if any clinical studies in PTCL, and no significant treatment advancements.
Should the European Commission approve the drug combination, it will be the sixth approved indication for brentuximab vedotin in Europe. Other indications include the treatment of adult patients with previously untreated CD30-positive stage IV Hodgkin lymphoma in combination with doxorubicin, vinblastine, and dacarbazine; the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplantation; the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT or at least to prior therapies when ASCT or multi-agent chemotherapy is not a treatment option; the treatment of adult patients with relapsed or refractory sALCL; and the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma after at least one prior systemic therapy.