European Commission Extends Conditional Market Authorization for Brentuximab Vedotin

Following a positive opinion from the Committee for Medicinal Products for Human Use issued on May 26, 2016, the European Commission (EC) has extended the current conditional marketing authorization of brentuximab vedotin (Adcetris®/Seattle Genetics/Takeda Oncology). The drug is now approved for the treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplant or ASCT. 

Based on this decision brentuximab vedotin is now approved for marketing of this indication in the 28 member states of the European Union, Norway, Liechtenstein and Iceland.

Approval process
In October 2012 Brentuximab vedotin was granted conditional marketing authorization by the European Commission. The approval was for two different indications.  The first indication was for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.

At the same time the European Commission granted marketing authorization for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).

Then, earlier this year, in January, the European Commission approved a Type II variation to include data on the retreatment of adult patients with relapsed or refractory Hodgkin lymphoma or relapsed or refractory sALCL who previously responded to brentuximab vedotin and who later relapse.

Brentuximab vedotin
Brentuximab vedotin is an antibody-drug conjugate or ADC comprising an anti-CD30 monoclonal antibody (SGN-30, a chimerized IgG1 monoclonal antibody specific for CD30) attached by a protease-cleavable dipeptide linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing proprietary technology developed by Seattle Genetics.

The drug employs a linker system that is designed to be stable in the bloodstream but to release MMAE, an anti-neoplastic selective to CD30-expressing tumor cells resulting in apoptotic death, upon internalization into these cells.

Because antibody-drug conjugates deliver cell-killing cytotoxic agents directly to the target (cancer) cell, they spare non-targeted cells and thereby reducing the toxic effects of traditional chemotherapy.

Development
Seattle Genetics and Takeda Pharmaceutical Company are collaborating in developing brentuximab vedotin. As part of their agreement, Seattle Genetics continues commercialization of the drug in the United States and Canadian while Takeda does the same in the rest of the world. The companies are funding joint worldwide development costs on a 50:50 basis, except in Japan where Takeda is fully responsible for development costs.

“With the European Commission approval, brentuximab vedotin becomes the first and only consolidation treatment option available in both the United States and European Union for high risk classical Hodgkin lymphoma patients to preserve their remission post-transplant,” noted Clay Siegall, PhD, President and Chief Executive Officer of Seattle Genetics, the co-developer of the drug. 

“This [decision] continues to support [the] goal to establish brentuximab vedtion as the global foundation of therapy for classical Hodgkin lymphoma and CD30-expressing lymphomas and provides a meaningful advance for cancer patients,” Siegall added.

Further reading
For a full article about the extension of the conditional market authorization go to ADC Review / Journal of Antibody-drug Conjugates: European Commission Approves Brentuximab Vedotin for Consolidation ...


Last editorial review: July 11, 2016. Copyright © 2016 Sunvalley Communication, LLC. All rights reserved. Republication or redistribution of Sunvalley Communication content, including by framing or similar means, is expressly prohibited without the prior written consent of Sunvalley Communication. Sunvalley Communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Onco'Zine and Oncozine are registered trademarks and trademarks of Sunvalley Communication around the world.

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