Date: 2012-07-20
Type of information: Granting of a Market Authorisation in the EU
Product name: Adcetris®
Compound: brentuximab vedotin
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism:
- antibody drug conjugate. Adcetris® (brentuximab vedotin) is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE). The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalisation into CD30-expressing tumor cells.
The CD30 antibody part of the product acts as a carrier for the cytotoxic substance. When the antibody attached by the linker to the cytotoxin attaches to the CTCL cells, it is taken up by the cells. Once inside the cancer cells, the linker is cut and the cytotoxic molecule, monomethyl auristatin E, gets released and stops cell division. The cancer cells are then expected to undergo programmed cell death.
The anti-tumour activity of brentuximab-vedotin has been established in the HL and sALCL study populations as well as in the relapsed or refractory HL patients ineligible for ASCT/multidrug chemotherapy. The different clinical endpoints demonstrated clinical benefit in terms of disease control, resolution of B-symptoms and in terms of enabling further potentially curative treatment options.
- Seattle Genetics and Millennium are jointly developing Adcetris®. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize Adcetris® in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs. In April 2012, Seattle Genetics and Millennium, a wholly owned subsidiary of Takeda Pharmaceutical Company have formed a collaboration with Ventana Medical Systems. Under the collaboration agreement, Ventana will seek to develop, manufacture and commercialize a molecular companion diagnostic test with the goal of identifying patients who might respond to treatment with Adcetris® based on CD30 expression levels in their tissue specimens.
Company: Takeda Global Research and Development Centre (UK), subsidiary of Takeda Pharmaceutical (Japan)
Disease:
- relapsed or refractory CD30+ Hodgkin lymphoma (HL):
(1) following autologous stem cell transplant (ASCT) or
(2) following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option
- treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
Latest news:
- • On October 31, 2012, Takeda Pharmaceutical and Millennium have announced that the European Commission has granted conditional marketing authorisation for Adcetris® (brentuximab vedotin) for two indications:
- (1) the treatment of adult patients with relapsed or refractory CD30 positive Hodgkin lymphoma (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, and
- (2) for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
Takeda intends to launch brentuximab vedotin across Europe, with the first launches planned in the coming weeks. Adcetris® was designated as an orphan medicinal product in Europe for both HL and ALCL by the Committee for Orphan Medicinal Products (COMP) on 15 January 2009.
- • On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Adcetris®, 50 mg, powder for concentrate for solution for infusion, intended for the treatment of of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): (1) following autologous stem cell transplant (ASCT) or (2) following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option as well as for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
The most common side effects are peripheral sensory neuropathy, fatigue, nausea, diarrhoea, neutropenia, vomiting, pyrexia, and upper respiratory tract infection.
A pharmacovigilance plan for Adcetris will be implemented as part of the marketing authorisation.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2011-08-17 (Seattle Genetics)
UE authorization: 2012-10-31
Favourable opinion UE: 2012-07-19
Favourable opinion USA:
Orphan status USA: 2007-01-30 (Hodgkin lymphoma) - 2008 -10 -23 (anaplastic large cell lymphoma)
Orphan status UE: 2009-01-15
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
- • On April 8, 2014, Seattle Genetics has announced that it will receive milestone payments from Takeda Pharmaceutical Company Limited (Takeda) totaling $6 million as a result of achieving the first commercial sale of Adcetris® (brentuximab vedotin) in three key countries in Takeda’s territories outside of the European Union and Japan, consisting of Australia, South Korea and Mexico. All three countries have permission to sell commercial product from their local health authority for the treatment of patients with relapsed or refractory CD30-positive Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). In addition to these three countries, Adcetris® is also commercially available in the U.S., European Union, Japan, Canada, Ukraine, Switzerland, Singapore, Norway, Liechtenstein and Iceland.
Is general: Yes
