Takeda Pulls FDA Application for Expanded Use of Cancer Drug Velcade
sNDA covering follicular lymphoma was withdrawn after discussions with regulatory agency.
Millennium: The Takeda Oncology Company has decided to withdraw its sNDA for Velcade in combination with rituximab for the treatment of relapsed follicular lymphoma, citing “business reasons.” The decision was made after further evaluation based on discussions with external advisors and FDA.
In the U.S. Velcade is approved for use in patients with multiple myeloma and those with mantle cell lymphoma who have received at least one prior therapy. In follicular lymphoma, Millennium says that it will continue to support evaluation of the drug in various patient subgroups including diffuse large B-cell lymphoma. The compound is also being tested in clinical trials of previously untreated mantle cell lymphoma.
The LYM-3001 trial findings were presented at the American Society of Hematology meeting in 2010 and published in Lancet Oncology in July 2011. The addition of Velcade to rituximab demonstrated a 1.8-month improvement in median progression-free survival (PFS) compared with rituximab alone.
The LYM-3001 trial randomized 676 patients with relapsed follicular lymphoma to receive Velcade and rituximab or rituximab alone. The primary endpoint of the trial was progression-free survival. The most common adverse events of grade 3 or higher were neutropenia (11% in the Velcade-rituximab arm and 4% in the rituximab arm), infection (11% and 4%, respectively), diarrhea (7% and 0%, respectively), herpes zoster (4% and < 1%, respectively), nausea or vomiting (3% and < 1%, respectively), and thrombocytopenia (3% and < 1%, respectively).
Velcade is co-developed by Millennium and Ortho Biotech Oncology Research & Development, a unit of Johnson & Johnson Pharmaceutical Research & Development. Millennium is responsible for commercialization in the U.S., while Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Takeda Pharmaceutical and Janssen Pharmaceutical co-promote the drug in Japan. Velcade is approved in more than 90 countries and has reportedly been used to treat more than 300,000 patients worldwide.