Almost two years ago, I learned Millennium was working on a new, more convenient way to administer Velcade. Subcutaneous (subq for short) administration–shots given with a small needle just under the skin, often in the belly–would cost less and save nurses and patients time.
At ASH, I learned European trials of subq Velcade were moving forward faster than expected. What I didn’t know were there might be additional benefits to this new treatment method. Here is a press release from Millennium and their new subq delivery system:
SUBCUTANEOUS ADMINISTRATION OF SINGLE-AGENT VELCADE DEMONSTRATES EFFICACY CONSISTENT WITH INTRAVENOUS ADMINISTRATION
–Overall Response Rate 42 Percent in Both Arms–
–Subcutaneous Administration Shows 63 Percent Reduction in Severe Peripheral Neuropathy–
Orlando, Fla., December 7, 2010 – Millennium: The Takeda Oncology Company today reported results from a randomized, international Phase III clinical trial comparing subcutaneous and intravenous administration of VELCADE® (bortezomib) in patients with relapsed multiple myeloma (MM). These data were presented at the 52nd annual meeting of the American Society of Hematology (ASH), held December 4-7 in Orlando, Florida.
“The most important finding of this study was the dramatic reduction in peripheral neuropathy with subcutaneous administration of VELCADE, making it an attractive route of administration,” said Philippe Moreau, M.D., University Hospital, Nantes, France.
The open-label, international, Phase III non-inferiority study was conducted in 222 patients with relapsed MM and compared the overall response rates (ORR) after 12 weeks of treatment with subcutaneous or intravenous VELCADE. The secondary endpoints of the study included ORR after 24 weeks, time to tumor progression (TTP), progression free survival (PFS), one-year overall survival (OS) and safety and tolerability of the two routes of administration. The results, which were presented by Professor Moreau, showed that the efficacy of subcutaneous and intravenous VELCADE was similar, and that subcutaneous VELCADE appeared to be associated with an improved safety profile over intravenous VELCADE.
“Subcutaneous administration upheld the established efficacy of VELCADE,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium. “Both routes of administration showed consistent results across all efficacy endpoints, including time to progression and overall survival.”
This is truly exciting news! All of it. More convenient, less neuropathy, improved safety profile. I will see if I can get a quote from Millennium when they expect FDA approval.
Feel good and keep smiling! Pat