Millennium, a Cambridge subsidiary of the Japanese drugmaker Takeda Pharmaceuticals International, said that US health regulators have expanded approval of Velcade for a rare form of blood cancer.
The US Food and Drug Administration (FDA) approved Velcade (bortezomib) for injection for use in previously untreated patients with mantle cell lymphoma (MCL), a rare, aggressive type of B-cell non-Hodgkin lymphoma (NHL) that typically occurs in older adults.
Velcade was first approved in 2003 to treat multiple myeloma, and then gained additional approval in 2006 for use in patients with relapsed or refractory MCL. Now the drug becomes the first treatment available in the US approved for use in previously untreated patients with MCL.
The approval is based on results from a head-to-head Phase III study that showed that previously untreated patients receiving Velcade-containing combination (VcR-CAP) experienced a 59 percent relative improvement in the study’s primary endpoint of progression-free survival (PFS) compared to those who were administered standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) regimen. The study evaluated the safety and efficacy of VcR-CAP vs R-CHOP in 487 patients with previously untreated MCL who were ineligible or not considered for a bone marrow transplant. The complete response (CR) rate for patients receiving VcR-CAP vs. R-CHOP was 44 percent versus 34 percent, respectively.
“We are delighted Velcade has received approval in previously untreated mantle cell lymphoma. The Velcade-combination delivered an 11-month median advantage in progression-free survival as compared to a current standard of care,” said Dixie-Lee Esseltine, MD, FRCPC, Vice President, Oncology Clinical Research, Takeda Pharmaceuticals International Co. “Since 2006, Velcade has proven to be an important therapy for the treatment of relapsed or refractory mantle cell lymphoma, and it can now be used as an initial treatment for all patients with mantle cell lymphoma.”
MCL constitutes about six percent of cases of NHL. The disease typically starts in the lymph nodes, but can spread to other tissues, such as bone marrow and liver. The expected overall survival for MCL is four to five years. The five-year survival rate for patients with advanced stage MCL is approximately 50 percent.
Millennium was acquired by Takeda in 2008. The company is will soon change its name to Takeda Oncology.
Last updated: 10/10/14; 11:25am EST