FDA Approves Takeda's Velcade For Multiple Myeloma Retreatment

Takeda Pharmaceutical Company and Millennium: The Takeda Oncology Company announced in a press release that the Food and Drug Administration (FDA) has approved Velcade (bortezomib) to retreat multiple myeloma (MM) patients. The approved Supplemental New Drug Application (sNDA) updates the label to include dosing guidelines for patients previously treated with Velcade who have relapsed. The safety and efficacy findings are included for Velcade as a single treatment or in combination with dexamethasone.

Michael Vasconcelles, MD, Global Head of the Oncology Therapeutic Area Unit at Takeda, said, “With these newly approved dosing guidelines, physicians will be able to provide their patients, who have previously received Velcade, with an effective treatment extending Velcade use across the continuum of care of multiple myeloma.”

Velcade

The FDA has provided guidance on Velcade. The agency first approved the drug in 2003 for refractory multiple myeloma and approved it in 2005 for MM patients who had received at least one prior therapy. In 2008, the FDA approved Velcade for the treatment of patients with multiple myeloma. The agent is a proteasome inhibitor, which blocks the activity of proteasomes — cell enzymes that regulate cell growth. The inhibition leads to cancer cell death but also kills good cells, leading to side effects.  

FDA Action

The FDA’s approval of Takeda’s sNDA was due in part to supportive data and a Phase II study. The Phase II RETRIEVE trial results were published in the British Journal of Haematology in January 2013. The study showed a 38.5 percent overall response rate (ORR) in patients previously treated with Velcade. 

Phase II Velcade Study

The Phase II Velcade Study titled, “A prospective, international phase 2 study of bortezomib retreatment in patients with relapsed multiple myeloma,” concluded that, “Bortezomib retreatment was effective and tolerable in relapsed MM patients, with no evidence of cumulative toxicities.”

In the study, 130 patients enrolled and 28 percent received bortezomib while 72 percent received bortezomib-dexamethasone. The primary endpoint of best confirmed response was met as the overall response rate was almost 40 percent. One patient responded completely while 49 patients showed a partial response. Of those 50 patients, the average response was 6.5 months. The adverse reaction rate was 12.3 percent and included thrombocytopenia, diarrhea, herpes zoster, and pneumonia. Due to adverse reactions, 13 percent of patients withdrew from the study.