FDA Extends Takeda's Velcade Indication In MCL
By Cyndi Root
The Food and Drug Administration (FDA) has extended the indication for Millennium’s and Takeda’s Velcade (bortezomib) to include previously untreated patients with mantle cell lymphoma (MCL). The indication extension was announced in a press release, which stated that the treatment is the first FDA approval for newly diagnosed MCL patients. Co-developed by Takeda and Janssen, Velcade has been approved by the FDA for relapsed or refractory MCL patients since 2006.
Dixie-Lee Esseltine, MD, FRCPC, VP of Oncology Clinical Research at Takeda, said, “Velcade delivered an 11-month median advantage in progression-free survival as compared to a current standard of care.”
Velcade
Velcade (bortezomib) is a proteasome inhibitor that blocks the activity of proteasomes, which are responsible for breaking down proteins in healthy or unhealthy cells. Inhibiting the proteasomes can cause cancer cell death.
Velcade is approved in the U.S. for MCL patients who have received at least one prior treatment. In August 2014, the FDA approved Velcade to retreat multiple myeloma (MM) patients. The agent is approved in 53 countries for MCL and in 90 countries for MM. Millennium markets Velcade in the U.S., and Janssen markets it in Europe and worldwide, except for Japan where Janssen and Takeda co-promote it.
The FDA based the indication extension, in part, on an international Phase 3 study. The trial showed that previously untreated patients who received a Velcade combination (VcR-CAP) improved 59 percent compared to patients who received a standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen. VcR-CAP patients experienced a 44 percent complete response rate compared to 34 percent for R-CHOP patients.
About Millennium
Millennium: The Takeda Oncology Company is a subsidiary of Takeda Pharmaceutical Company Limited. Millennium started in the U.S. as a genomics company. Currently, the company is developing mifamurtide (MTP-PE) for osteosarcoma, a bone cancer in children and young adults. Under the brand name Mepact, mifamurtide has been approved in Europe since 2009. According to the European Medicines Agency, mifamurtide is used with other anticancer medicines and has demonstrated its ability to increase survival rates.