A close up of nodular lymphocyte predominant Hodgkin lymphoma (Gabriel Caponetti)
Takeda has filed for approval in Japan of brentuximab vedotin, its antibody-drug conjugate (ADC) for two forms of lymphoma.
The drug – which has already been approved in the US and Europe under the Adcetris brand name – has been filed in Japan as a treatment for adult patients with CD30-positive relapsed or refractory Hodgkin’s lymphoma (HL) and relapsed or refractory anaplastic large cell lymphoma (ALCL).
Takeda said its submission to the Ministry of Health, Labour and Welfare (MHLW) is based on a pivotal phase I/II study of the ADC conducted in Japan by its Takeda Bio Development Centre, as well as two international phase II studies.
In March 2012, the MHLW granted brentuximab vedotin orphan product designations for the treatment of patients with HL and ALCL in Japan.
The drug was originally developed by Takeda’s Millennium subsidiary and Seattle Genetics and has been available in the US since August 2011, with Seattle reporting North American sales last year of $136m.
Takeda, which has rights to the drug outside the US and Canada, was given a green light by the European Medicines Agency (EMA) in October 2012, and says it is now hoping to offer it to patients in Japan “as quickly as possible”.
Estimates of brentuximab vedotin’s peak sales potential vary from as little $500m a year to blockbuster status if Seattle Genetics and Takeda/Millennium can expand its use into additional indications.
The partners are working on trials to expand the ADC’s use into earlier stages of therapy in HL and ALCL, as well as into new malignancies that express CD30 antigens, the target of the antibody component of the drug.
At the moment Adcetris is in more than a dozen trials, including two phase III studies which are looking at its role in first-line therapy (ECHELON-1 and 2), as a maintenance therapy for stem cell transplant, and in mature and cutaneous T cell lymphomas.
