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news.Seattle Genetics, a clinical stage biotechnology company, has announced that its antibody-drug conjugate SGN-35 has received the orphan drug designation from the European Medicines Agency for the treatment of Hodgkin lymphoma and anaplastic large cell lymphoma, or ALCL, and from the FDA for the treatment of ALCL.
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These designations are in addition to the SGN-35 orphan drug designation for Hodgkin lymphoma previously received from the FDA. The company plans to initiate a pivotal trial of SGN-35 for Hodgkin lymphoma and a Phase II clinical trial for ALCL during the first quarter of 2009.
The FDA’s orphan drug designation will provide Seattle Genetics with seven years of marketing exclusivity for each indication, Hodgkin lymphoma and ALCL, if SGN-35 is approved by the FDA in such indication.
The European Medicines Agency’s orphan medicinal product designation will provide 10 years of marketing exclusivity if the product candidate is approved for marketing for the designated orphan indication in the EU.
Thomas Reynolds, chief medical officer of Seattle Genetics, said: These orphan drug designations support our global development strategy for SGN-35 and assist in achieving our goal of providing improved therapies for patients with Hodgkin lymphoma and ALCL.
Our clinical experience to date with SGN-35 has demonstrated its potential to induce objective responses, including complete remissions, in relapsed or refractory Hodgkin lymphoma and ALCL where limited treatment options exist. This activity paired with a favorable tolerability profile supports our plans to initiate a pivotal trial of SGN-35 this quarter under a special protocol assessment.