Oncology Central

Bortezomib US FDA approved for previously untreated mantle cell lymphoma

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Bortezomib (VELCADE®) is the first treatment to be approved in the US for use in patients with previously untreated mantle cell lymphoma (MCL). Previously, the drug was only available for use in relapsed or refractory MCL patients. The US FDA have recently approved the extended use of bortezomib based on the results of an international, randomized, head-to-head Phase III study led by Millennium: The Takeda Oncology Company and the Takeda Pharmaceutical Company Limited (Osaka, Japan).

Mantle cell lymphoma is a rare and aggressive type of B-cell non-Hodgkin lymphoma, which is associated with a high risk of relapse, making it a difficult disease to treat. The expected overall survival for MCL patients is approximately 4–5 years and the 5-year survival rate for advanced stage MCL is approximately 50%.

The results from this Phase III study demonstrated that previously untreated MCL patients receiving a bortezomib-containing combination therapy (the VcR-CAP regimen) experienced a 59% improvement in progression-free survival at a median follow-up of 40 months, compared with those who were administered the standard R-CHOP regimen.

The open-label prospective study evaluated the efficacy and safety of bortezomib in 487 MCL patients who could not be considered for bone marrow transplant. Bortezomib (1.3 mg / m2) was administered intravenously in combination with intravenous rituximab, cyclophosphamide, doxorubicin and oral prednisone for six 3-week treatment cycles.

Adverse reactions leading to discontinuation of treatment occurred in 8% of patients receiving bortezomib-containing regimen, compared with 6% of patients receiving traditional R-CHOP treatment. In the bortezomib group, the most common adverse reaction leading to discontinuation was peripheral sensory neuropathy.

“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,” commented Dixie-Lee Esseltine, Vice President of Oncology Clinical Research at Takeda Pharmaceuticals International Ltd. “Since 2006, VELCADE has proven to be an important therapy for the treatment of relapsed or refractory MCL, and it can now be used as an initial treatment for all patients with MCL.”

Source: Takeda Pharmaceutical Company Limited press release

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