07.12.2013 17:02:38

Takeda Announces Results From Subgroup Analysis Of Phase 3 VISTA Study

(RTTNews) - Millennium: The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited (TKPYY.PK, TKPHF.PK), announced results from a retrospective, subgroup analysis of the Phase 3 VISTA study that showed a higher cumulative dose of VELCADE (bortezomib) suggested improved overall survival or OS in previously untreated patients with multiple myeloma or MM (hazard ratio [HR] 0.53; p<0.0001).

Patients who received a cumulative dose of VELCADE of 39 mg/m2 or greater lived 20 months longer on average than those who received lower cumulative doses (median OS 66.3 months and 46.2 months, respectively). The subgroups were determined post-randomization and the analysis was retrospective.

VELCADE is approved by the U.S. Food & Drug Administration (FDA) for the treatment of MM and relapsed mantle cell lymphoma or MCL.

VELCADE (bortezomib) is approved for the treatment of patients with multiple myeloma. VELCADE is also approved for the treatment of patients with mantle cell lymphoma who have already received at least one prior treatment.

The company advised that Patients should not receive VELCADE if they are allergic to bortezomib, boron or mannitol. VELCADE should not be administered intrathecally. Women should avoid becoming pregnant or breastfeeding while taking VELCADE. Patients with diabetes may require close monitoring and adjustment of their medication.

Common side effects seen in patients receiving VELCADE include: fever, decreased appetite, fatigue, rash.

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