AdcetrisTreatment for Lymphoma, Hodgkin's Disease, Mycosis Fungoides
Update: Adcetris (brentuximab vedotin) Now FDA Approved - August 19, 2011
Seattle Genetics Announces FDA Advisory Committee to Review Brentuximab Vedotin for the Treatment of Relapsed or Refractory Hodgkin Lymphoma and Systemic ALCL
BOTHELL, Wash.--(BUSINESS WIRE)--Jun 16, 2011 - Seattle Genetics, Inc. today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the company's Biologics License Applications (BLAs) for brentuximab vedotin (Adcetris™) on July 14, 2011. ODAC plans to review the BLA for the treatment of relapsed or refractory Hodgkin lymphoma during the morning session and the BLA for the treatment of relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) during the afternoon session. Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of Hodgkin lymphoma and ALCL.
ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes appropriate recommendations to the FDA. The FDA regulations indicate that although the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made by the FDA solely, and the recommendations by the panel are non-binding.
Seattle Genetics announced on May 2, 2011 that the FDA had accepted for filing two BLAs for brentuximab vedotin, including one for the treatment of relapsed or refractory Hodgkin lymphoma and one for the treatment of relapsed or refractory systemic ALCL. The FDA has granted a six-month priority review of both applications, and has established an action date of August 30, 2011 under the Prescription Drug User Fee Act (PDUFA). The BLAs for brentuximab vedotin are based on results from both a pivotal trial in relapsed or refractory Hodgkin lymphoma and a phase II trial in relapsed or refractory systemic ALCL. The pivotal trial in Hodgkin lymphoma was conducted under a Special Protocol Assessment (SPA) with the FDA. Brentuximab vedotin has been granted orphan drug designation by the FDA for the treatment of Hodgkin lymphoma and ALCL.
About Brentuximab Vedotin
Brentuximab vedotin (Adcetris) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a potent, synthetic drug, monomethyl auristatin E (MMAE) utilizing Seattle Genetics' proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. This approach is intended to spare non-targeted cells and thus may help minimize the potential toxic effects of traditional chemotherapy while allowing for the selective targeting of CD30-expressing cancer cells, thus potentially enhancing the antitumor activity.
Seattle Genetics is developing brentuximab vedotin in collaboration with Millennium: The Takeda Oncology Group. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize brentuximab vedotin in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for brentuximab vedotin on a 50:50 basis, except in Japan where Takeda will be solely responsible for development costs.
About Hodgkin Lymphoma
Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. A defining attribute of the Reed-Sternberg cell is its expression of the CD30 antigen.
According to the American Cancer Society, approximately 8,500 cases of Hodgkin lymphoma were diagnosed in the United States during 2010 and more than 1,300 people were expected to die from the disease. Although front-line combination chemotherapy can result in durable response rates, up to 30 percent of these patients relapse or are refractory to front-line treatment and have few therapeutic options beyond ASCT.
About Systemic ALCL
ALCL is an aggressive type of T-cell non-Hodgkin lymphoma that highly expresses CD30. In the United States, approximately 2,000 systemic ALCL patients are diagnosed annually. Although front-line combination chemotherapy can result in durable remissions, approximately 50 percent of ALCL patients relapse or are refractory to front-line treatment and have few therapeutic options.
About Seattle Genetics
Seattle Genetics is a clinical-stage biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer and autoimmune disease. The U.S. Food and Drug Administration has granted priority review to Biologics License Applications for its lead product candidate, brentuximab vedotin, for the treatment of relapsed or refractory Hodgkin lymphoma and relapsed or refractory systemic anaplastic large cell lymphoma, with a PDUFA date of August 30, 2011. Brentuximab vedotin is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has five other clinical-stage programs: SGN-75, ASG-5ME, ASG-22ME, dacetuzumab (SGN-40) and SGN-70. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. More information can be found at www.seattlegenetics.com.
Certain of the statements made in this press release are forward looking, such as those, among others, relating to the company's expectations for regulatory approval and commercial launch of brentuximab vedotin. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that data from our pivotal Hodgkin lymphoma trial and phase II ALCL trial of brentuximab vedotin will not support marketing approval for the submitted indications. More information about the risks and uncertainties faced by Seattle Genetics is contained in the company's 10-Q for the quarter ended March 31, 2011 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact: Seattle Genetics, Inc.
Peggy Pinkston, 425-527-4160
Posted: June 2011
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- Seattle Genetics Announces FDA Accepts Brentuximab Vedotin BLAs for Filing and Grants Priority Review for Relapsed or Refractory Hodgkin Lymphoma and Systemic ALCL - May 2, 2011
- Seattle Genetics Submits BLA to FDA for Brentuximab Vedotin in Relapsed or Refractory Hodgkin Lymphoma and Systemic ALCL - February 28, 2011