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FDA Allows Important Labeling Change For Multiple Myeloma Drug Velcade

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FDA Allows Important Labeling Change For Multiple Myeloma Drug Velcade

The Tokeda Oncology Company (Millennium) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application for Velcade, which expandsthe label to include long-term (median follow-up 36.7 months) overall survival (OS) data from the landmark VISTA trial.

What the heck does this mean and why is it important? I immediately e-mailed my friend, Manisha Pai at Millennium, for her take on the news. Here is her response:

As you can guess, an FDA approval means Millennium is super-excited about this news, but it’s important to patients and docs, too. As we both know, in any cancer really, the goal of patients and the doctors who treat them is to prolong survival, to help patients live as long as possible. In MM, there’s a clear need for treatments that are unequivocally to help patients live longer, and VELCADE is now the first front-line MM therapy to have such long-term (three-year follow-up) data actually added to the—this survival data was from patient not eligible for stem-cell transplant—and also calls attention to the importance of prolonging overall survival for as long as possible.

OK. If you have been paying attention at all to this blog, or other multiple myeloma sources, you should know both Velcade and Celgene’s Revlimid are used by oncologists to treat multiple myeloma. In a majority of patients, either drug can be used to knock the myeloma down for months or years. Velcade is FDA approved for use on newly diagnosed patients. Revlimid is only approved for use after other therapies have been tried. However, many doctors use Revlimid “off label,” meaning they go ahead and use it in newly diagnosed patients as well. As a matter of fact, Revlimid actually outsells Velcade, probably because it is an oral medication.

So why is any of this labeling news important? Money. I picked-up this Millennium press release off the wires before the company forwarded me the information—and I’m on Millennium’s priority press contact list. So where did I find the release? From my financial sources at BusinessWire.Com, of course! This is a financial/business story, not a medical one. That doesn’t mean that Manisha isn’t sincere—or that everything she says about the drug isn’t true—or that it isn’t something patients need to know. It just means releases like this are ultimately intended to increase stock value and sell more product! This news gives Velcade an additional leg-up on Revlimid—one more reason for oncology docs to reach for Velcade first. It also has insurance implications. It will now be easier for a patient to get treatment approved by their insurance company. And that may be the news which benefits patients most of all.

Feel good and keep smiling! Pat