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Takeda's Adcetris secures expanded approval in Europe for untreated CD30+ Stage IV Hodgkin lymphoma

Published on 14/02/19 at 12:58pm

Takeda’s Adcetris (brentuximab vedotin) has seen its marketing authorisation expanded by the European Commission to include the treatment of previously untreated CD30+ Stage IV Hodgkin lymphoma in combination with AVD (Adriamycin, vinblastine and dacarbazine) in adult patients.

Phase 3 data submitted to support the indication had demonstrated that use of the drug in combination with AVD led to a “statistically significant improvement in modified progression-free survival (PFS)” compared to ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine), meeting its primary endpoint; risk of progression, death or need for additional anticancer therapy was reduced by 23%.

The safety profile for Adcetris plus AVD was found to be generally consistent with previous studies on the drug alone. The drug was previously recommended in December last year by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

“The decision by the European Commission is a welcomed advancement for patients with previously untreated Stage IV Hodgkin lymphoma – a population that has not been offered a new treatment option in decades,” remarked Dr Anna Sureda, Head of the Hematology Department and Hematopoietic Stem Cell Transplant Programme at Institut Català d'Oncologia – Hospital Duran i Reynals. “Patients with Stage 4 disease carry a higher risk of progression following their first therapy and experience poorer outcomes as a result. The approval of this regimen may help address this unmet need by providing European physicians and their patients with a new option that showed significant benefit compared to ABVD along with a safety profile consistent with when Adcetris is used as a single agent.”

Dr Jesús Gómez-Navarro, Vice President, Head of Oncology Clinical Research and Development at Takeda, also noted: “We are pleased that the European Commission has approved Adcetris in combination with AVD, which has the potential to represent an important milestone for patients and serves as a testament to Takeda’s longstanding commitment to the Hodgkin lymphoma community. The ECHELON-1 clinical trial demonstrated that the addition of Adcetris and the removal of bleomycin from the standard ABVD regimen yielded both efficacy and safety benefits in patients. We look forward to making this therapy available for appropriate European patients with Hodgkin lymphoma.”

Matt Fellows

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