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FDA Approved for Multiple Myeloma treatment: Bortezomib (formerly PS-341) VELCADE SUBCUTANEOUSLY

Updated: Oct 19, 2021

01/23/2012: FDA Approves Subcutaneous Administration of VELCADE® In All Approved Indications

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE®(bortezomib), which updates the label to include the subcutaneous method of administration in all approved indications: multiple myeloma and mantle cell lymphoma after at least one prior therapy.

The approval was based on results from a randomized, phase 3, open-label, international, non-inferiority trial conducted in 222 bortezomib-naïve patients with relapsed multiple myeloma (MM). The primary (non-inferiority) objective of the trial was to demonstrate that single agent subcutaneous VELCADE retained at least 60 percent of the overall response rate (ORR) after 4 cycles relative to single agent intravenous VELCADE. Patients in both arms who did not obtain an optimal response (less than complete response (CR)) to therapy with VELCADE alone after 4 cycles were allowed to receive 20 mg of oral dexamethasone daily on the day of and after VELCADE administration. The secondary endpoints of the study included safety and tolerability, ORR and CR rate after 8 cycles, time to progression (TTP), progression free survival (PFS), and one-year overall survival (OS) of the two routes of administration.

Subcutaneous Administration

The pivotal study, published in the Lancet Oncology in May 2011, met its primary efficacy endpoint. Patients receiving VELCADE subcutaneously achieved a 4-cycle ORR of 43 percent and CR rate of 7 percent, while patients receiving VELCADE intravenously achieved an ORR of 42 percent and a CR rate of 8 percent.

A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma


Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study

Lancet Oncol;2011 May

01/23/2012: FDA Approval Velcade subcutaneously



Bortezomib (formerly PS-341), a promising new drug for the treatment of multiple myeloma, recently received accelerated approval from the U.S. Food and Drug Administration (FDA) for the therapy of patients with progressive myeloma after previous treatment. Two phase II studies of bortezomib used the same schedule of twice-weekly i.v. dosing for the first 2 weeks of each 3-week cycle. In a randomized study of 54 patients, two doses were compared (1.0 and 1.3 mg/m2) and objective responses occurred at both dose levels (23% versus 35%), including one complete response in each arm.

On May 13, 2003, the U.S. Food and Drug Administration (FDA) granted accelerated approval for bortezomib (formerly PS-341), Velcade® for Injection (Millenium Pharmaceuticals, Inc.; Cambridge, MA), for use as a single agent for the treatment of patients with multiple myeloma after two prior therapies and progressing on their most recent therapy. In 1998, Millennium Pharmaceuticals, Inc., submitted an Investigational New Drug Application for bortezomib and in January, 2003, a New Drug Application (NDA) was filed. At the time of the NDA submission, melphalan, cyclophosphamide, and carmustine had been FDA approved for myeloma treatment

  • Phase I trial of the proteasome inhibitor PS-341 in patients with refractory hematologic malignancies Conclusion: PS-341 was well tolerated at 1.04 mg/m(2) on this dose-intensive schedule, although patients need to be monitored for electrolyte abnormalities and late toxicities. Additional studies are indicated to determine whether incorporation of dose/body surface area yields a superior PD model to dosing without normalization. PS-341 showed activity against refractory multiple myeloma and possibly non-Hodgkin's lymphoma in this study, and merits further investigation in these populations.

  • A phase I trial of the novel proteasome inhibitor PS341 in advanced solid tumor malignancies. Clin Cancer Res; 2002 Aug

  • A phase 2 study of bortezomib in relapsed, refractory myeloma N Engl J Med;2003 Conclusions: Bortezomib, a member of a new class of anticancer drugs, is active in patients with relapsed multiple myeloma that is refractory to conventional chemotherapy.

  • Bortezomib (Velcade™) in the Treatment of Multiple Myeloma

  • PS-341 (VELCADE™) Versus High-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma Phase 3 Official Title: An International, Multi-Center, Randomized, Open-Label Study of PS-341 (VELCADE™) Versus High-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma This study will compare the efficacy of PS-341 versus high dose dexamethasone. NCT00048230 2002 Millennium Pharmaceuticals, Inc.


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