Takeda's Adcetris (brentuximab vedotin) has been given the regulatory go-head in Japan to treat malignant lymphoma.
More specifically, the Japanese Ministry of Health, Labour and Welfare (MHLW) has issued a green light for its use in patients with CD30 Positive Relapsed or Refractory Hodgkin Lymphoma (HL) or Relapsed or Refractory Anaplastic Large Cell Lymphoma (ALCL).
The drug was assigned orphan drug designation in Japan in March 2012, and the MHLW go-ahead comes on the back of data from a Phase I/II clinical trial in Japanese patients and two global pivotal Phase II clinical trials, the firm said.
Adcetris is an antibody-drug conjugate made up of an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent using Seattle Genetics' proprietary technology, which basically enables release of the active substance into CD30-expressing tumour cells after ingestion.
The drug is already approved in 39 countries, including the US (since August 2011) and Europe (since October 2012).
"Until now, patients in Japan with relapsed or refractory Hodgkin lymphoma or ALCL had few therapeutic treatment options, and the approval of Adcetris represents a significant milestone in making this innovative targeted therapy available to these patients in need," said Clay Siegall, president and chief executive of partner Seattle Genetics.
The companies are jointly developing Adcetris under an agreement that has given Seattle commercialisation rights in the US and Canada and Takeda rights in the rest of the world. As per the deal, development costs are being shared on a 50:50 basis everywhere except in Japan, where Takeda is picking up the tab by itself.
Seattle stands to receive two milestone payments from Takeda totalling $9 million after pricing agreement in Japan is reached.