Additional Route of Administration Approved for Velcade

Share this content:
Millennium and its parent company Takeda announced that the FDA has approved Velcade (bortezomib) for subcutaneous administration in the management of multiple myeloma and mantle cell lymphoma after at least one prior therapy. This approval was based on results from a randomized, Phase 3, open-label, international, non-inferiority trial conducted in 222 bortezomib-naive patients with relapsed multiple myeloma. The primary objective of the trial was to demonstrate that single-agent subcutaneous Velcade retained at least 60% of the overall response rate (ORR) after four cycles relative to single agent intravenous Velcade.

Patients receiving Velcade subcutaneously achieved a 4-cycle ORR of 43% and complete response (CR) rate of 7%, while patients receiving Velcade intravenously achieved an ORR of 42% and a complete response rate of 8%. The overall safety profile was similar between the two arms. However, differences were observed in the incidence of peripheral neuropathy (PN). In the subcutaneous arm of the trial, 6% of patients experienced PN of grade 3 or higher, compared with 16% in the intravenous arm. In the subcutaneous arm, 38% of patients experienced PN of all grades, compared with 53% of patients in the intravenous arm.

For more information, call (800) 589-9005 or visit
You must be a registered member of Cancer Therapy Advisor to post a comment.

Regimen and Drug Listings


Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs

Sign Up for Free e-newsletters