|Seattle Genetics Announces Unanimous Recommendations from FDA Advisory Committee in Favor of Accelerated Approval of ADCETRIS(TM) for Post-Transplant Relapsed Hodgkin Lymphoma and Relapsed or Refractory Systemic ALCL|
BOTHELL, Wash., Jul 14, 2011 (BUSINESS WIRE) -- Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that the Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration (FDA) voted 10-0 to recommend that the FDA grant accelerated approval of ADCETRIS(TM) (brentuximab vedotin) for the treatment of patients with Hodgkin lymphoma who relapse after autologous stem cell transplant (ASCT). In addition, ODAC voted 10-0 to recommend that the FDA grant accelerated approval of ADCETRIS for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). The FDA is expected to act on the two Biologics License Applications (BLAs) for ADCETRIS by August 30, 2011 under the Prescription Drug User Fee Act (PDUFA). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of Hodgkin lymphoma and ALCL.
"The recommendations by the ODAC panels today are another significant step forward in our development of ADCETRIS," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "If approved, ADCETRIS would be the first in a new class of ADCs, utilizing stable linkers and potent cytotoxic payloads. We look forward to continuing to interact with the FDA in its evaluation of ADCETRIS towards our goal of bringing this CD30-directed drug to patients in need."
The ADCETRIS BLAs were based primarily on data from a pivotal trial in relapsed or refractory Hodgkin lymphoma that was conducted under a Special Protocol Assessment with the FDA and from a phase II trial in relapsed or refractory systemic ALCL. The FDA is not obligated to follow the guidance of advisory committee panels but normally takes its advice into consideration before making its final decision on approval.
Conference Call Details
Seattle Genetics' management will host a conference call and webcast to discuss the ODAC recommendations. The call will be held tomorrow, July 15, 2011, at 8:30 a.m. Eastern Time (ET). The live event will be available from Seattle Genetics' website at http://www.seattlegenetics.com, under the Investors and News section, or by calling (800) 762-8779 (domestic) or (480) 629-9771 (international). The access code is 4456034. A replay of the discussion will be available beginning at approximately 10:30 a.m. ET on July 15 from Seattle Genetics' website or by calling (800) 406-7325 (domestic) or (303) 590-3030 (international), using access code 4456034 The telephone replay will be available until 5:00 p.m. ET on Tuesday, July 18, 2011.
ADCETRIS (brentuximab vedotin) 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 ADCETRIS in collaboration with Millennium: The Takeda Oncology Company. 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. In June 2011, the European Medicines Agency accepted the filing of a Marketing Authorization Application (MAA) for ADCETRIS for the treatment of relapsed or refractory Hodgkin lymphoma (HL) and relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). Seattle Genetics and the Takeda Group are funding joint development costs for ADCETRIS 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, more than 8,800 cases of Hodgkin lymphoma will be diagnosed in the United States during 2011 and approximately 1,300 people are 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, ADCETRIS, 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. ADCETRIS 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 http://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 ADCETRIS. 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 ADCETRIS will not support marketing approval for the submitted indications or that we are not able to establish sufficient confirmatory clinical trials. 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.
SOURCE: Seattle Genetics, Inc.
Seattle Genetics, Inc.