Japan-based Takeda Pharmaceutical has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its new drug application (NDA) of ADCETRIS (brentuximab vedotin), intended for the treatment of patients with CD30-positive, relapsed or refractory hodgkin lymphoma (HL), or relapsed or refractory anaplastic large-cell lymphoma (ALCL).
Approval of the NDA is based on the results of a phase one and two clinical trial in Japanese patients with relapsed or refractory CD30-positive HL and patients with relapsed or refractory CD30-positive systemic ALCL.
Go deeper with GlobalData
The application approval was also based on data secured from two global pivotal phase two clinical trials.
Adcetris was also granted orphan drug designation by MHLW in March 2012, for the treatment of patients with HL and ALCL and therefore was targeted for priority review in Japan.
The company said that Adcetris, an antibody-drug conjugate (ADC), contains an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), using Seattle Genetics’ technology.
See Also:
The ADC utilises a linker system designed to be stable in the bloodstream, but to release MMAE upon internalisation into CD30-expressing tumour cells.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataTakeda’s head of the oncology therapeutic area unit Michael Vasconcelles said: "This approval brings us a step closer to providing a new treatment option to patients in Japan with relapsed or refractory HL and relapsed or refractory ALCL."
Adcetris was also granted accelerated approval by the US Food and Drug Administration in August 2011.
In February 2013, Health Canada also approved the drug for two indications, including the treatment of patients with HL after failure of autologous stem cell transplant (ASCT), or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and to treat patients with sALCL after failure of at least one after multi-agent chemotherapy regimen.
The European Commission granted conditional marketing authorisation in October 2012, for Adcetris to treat adult patients with relapsed or refractory CD30+ HL, following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.
In the US and Canada, Seattle Genetics has commercialisation rights to Adcetris, while Takeda has the right to commercialise the drug in all other countries.
Image: A high-power view of hodgkin lymphoma, nodular lymphocyte predominant. Photo: courtesy of Gabriel Caponetti.
