Adcetris (brentuximab vedotin) gets conditional european marketing authorization


Adcetris (brentuximab vedotin) gets conditional european marketing authorization


Adcetris (Brentuximab Vedotin) has been approved in the European Union for patients with certain types of lymphoma, Millennium announced today.

Adcetris has been approved in Europe for:

  • Adult patients with relapsed or refractory CD30 positive Hodgkin lymphoma after ASCT (autologous stem cell transplant), or after at least two previous treatments when ASCT or chemotherapy (multi-agent) is not an option for treatment.
  • Adults with relapsed/refractory sALCL (systemic anaplastic large cell lymphoma).
Adcetris was approved in the USA by the Food and Drug Administration in August 2011. Takeda says it plans to launch Adcetris across Europe within the next few weeks.

CHMP (Committee for Medicinal Products for Human Use) adopted a positive opinion for conditional marketing authorization of Adcetris on 19th July, 2012, after assessing the benefit-risk ratio for the above indications.

In the European Commission (EC), granting conditional marketing authorization means the drugmaker must provide more clinical data later on to confirm that the benefits outweigh the risks.

Professor Andreas Engert, M.D., University Hospital of Cologne, Germany, said:

"Adcetris has been shown to offer a high overall response rate, including durable complete responses in both of its indications. Conditional marketing authorization by the European Commission signifies an important advancement in the treatment of adult patients with these rare CD30 positive hematological cancers who are relapsed or refractory and previously had limited options."

Trevor Smith, Head of Commercial Operations, Europe & Canada, Takeda Pharmaceuticals, said:

"The European conditional marketing authorization of Adcetris represents a significant step in Takeda's oncology franchise commitment to developing innovative medicines that make a real difference to patients' lives. Adcetris is a new targeted therapeutic option for adult patients with relapsed or refractory Hodgkin lymphoma or relapsed or refractory systemic anaplastic large cell lymphoma, and Takeda looks forward to making it available in Europe."

Millenium (part of Takeda) and Seattle Genetics are developing brentuximab vedotin jointly. Seattle Genetics has Canadian and US commercialization rights, while the Takeda Group has the rest of the world. The two companies are paying equally towards the developing costs of brentuximab vedotin, except in Japan where Takeda pays for all of it.

About Adcetris (Brentuximab Vedotin)

Adcetris (brentuximab vedotin) is an ADC (antibody-drug conjugate) consisting of an anti-CD monoclonal antibody attached by a protease-cleavable linker to a MMAE (microtubule disrupting agent, monomethyl auristatin E).

The ADC uses a linker system that makes it stable in the bloodstream while releasing MMAE upon internalization into CD30-expressing tumor cells.

In a 2010 clinical trial, 34% of participants with refractory Hodgkin Lymphoma achieved complete remission, while another 40% had partial remission. 94% of patients experienced tumor reductions. 87% of patients with ALCL experienced tumor shrinkage of at least 50%, while 97% had some kind of tumor shrinkage.

A course of treatment with Adcetris may cost up to $100,000 in the USA.

Adcetris side effects include thrombocytopenia (low blood platelet levels), peripheral sensory neuropathy (nerve damage), neutropenia (drop in white blood cells), nausea, upper respiratory infection, diarrhea, vomiting, and anemia.

What is Hodgkin Lymphoma?

Lymphoma includes several cancers that start off in the lymphatic system. There are two main lymphoma categories:
  • Hodgkin lymphoma - this type has one characteristic type of cell which is not present in other lymphomas; "Reed-Sternberg cells". The Reed-Sternberg cell expresses CD30.
  • Non-Hodgkin lymphoma

What is Anaplastic Large Cell Lymphoma (ALCL)?

ALCL is a kind of aggressive T-cell lymphoma. Between 10% and 30% of all Non-Hodgkin lymphomas in children are of this type, and approximately 3% of adults. There are two types of ALCL: 1. Primary cutaneous ALCL. 2. Systemic ALCL (sALCL).

sALCL is the more aggressive one; it is systemic and mainly involves lymph nodes and expresses CD30.

Takeda bought Millennuim for $8.8 billion in 2008.


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Section Issues On Medicine: Disease