Takeda receives EU approval for new label update for Adcetris

Takeda has announced that the European Commission has approved a Type II label variation to update the available information for its cancer therapy Adcetris.

The product's labelling will be amended to include data on the retreatment of adult patients with relapsed or refractory Hodgkin lymphoma or systemic anaplastic large cell lymphoma (sALCL) who previously responded to Adcetris but have since relapsed.

This includes an update to the clinical sections, including safety, to incorporate data on retreatment of these patients, with the information based on the findings of a recent phase II clinical trial.

It is hoped that this will make it easier for patients to make use of retreatment in future, providing people with limited therapy options another chance to potentially benefit from the use of this drug.

Dr Dirk Huebner, executive medical director for Takeda's oncology therapeutic area unit, said: "We look forward to continuing our ongoing clinical program of Adcetris in Hodgkin lymphoma and sALCL, as well as in a variety of other forms of lymphoma, with the goal of bringing this important therapy to patients who might benefit from it."

Adcetris has received marketing authorisation from regulatory authorities in more than 55 countries, and was approved in Europe in October 2012.