Seattle Genetics, Inc. (Nasdaq: SGEN) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Adcetris (brentuximab vedotin) for two indications.
1. the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and
2. the treatment of patients with systemic anaplastic large cell lymphoma (ALCL) after failure of at least one prior multi-agent chemotherapy regimen.
[googlead tip=”lista_mare” aliniat=”stanga”]The indications for Adcetris are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with Adcetris.
Adcetris is the first drug approved by the FDA for Hodgkin lymphoma in more than 30 years, and provides a new therapeutic alternative for Hodgkin lymphoma and systemic ALCL in these settings.
Seattle Genetics expects to make Adcetris available to patients this week.
Adcetris is an antibody-drug conjugate (ADC) directed to CD30.
“Bringing a new product to the market is a significant milestone for Seattle Genetics in fulfilling its mission to improve the lives of people with cancer,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics.[googlead tip=”vertical_mediu” aliniat=”dreapta”]
“The approval of Adcetris is a result of more than a decade of research and development by talented scientists and physicians. The company has deep appreciation for the hundreds of patients who participated in Adcetris trials, and the passion and determination of the clinicians at sites around the world in investigating this first in a new class of targeted anticancer agents.We are committed to continued clinical investigation of Adcetris through a broad developmentprogram for CD30-positive malignancies, including confirmatory trials in front-line Hodgkin and T-cell lymphomas that we have planned in consultation with the FDA.”
“The marked single agent activity seen with Adcetris, including a high durable complete remission rate, offers an opportunity to improve the treatment paradigm of patients for whom the treatment is indicated,” said Owen A. O’Connor, M.D., Ph.D., Professor, and Director, Division of Hematology and Medical Oncology at NYU Cancer Institute.
“This approval represents a major advancement in the care of these patients.”
Seattle Genetics also announced that it has established a patient assistance program named SeaGenSecure™ that offers patients and providers access to Adcetris reimbursement support, benefit investigations and patient assistance programs.
Seattle Genetics is jointly developing Adcetris 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. Seattle Genetics and the Takeda Group are funding joint development costs for Adcetris on a 50:50 basis, except in Japan, where the Takeda Group will be solely responsible for development costs.