Millennium Wins FDA OK for New Velcade, Looks to Fend Off Onyx

Xconomy Boston — 

Millennium is the house that Velcade built, and today it’s gotten the green light to start marketing what it considers to be a new and improved version of the hit drug for multiple myeloma.

The Cambridge, MA-based cancer drug developer, part of Japan-based Takeda Pharmaceuticals, said today it has gotten clearance from the FDA to start marketing a version of bortezomib (Velcade) that can be injected just under the skin, in addition to the usual form given intravenously. Today’s approval means the subcutaneous form of Velcade can be used in every setting where the existing drug is prescribed, for patients with multiple myeloma and mantle cell lymphoma.

While this would ordinarily be considered an incremental advance by providing patients and physicians with a more convenient option, the new Velcade approval could be more meaningful. That’s because the new subcutaneous form of the drug appears to be more tolerable, causing fewer cases of nerve damage in the fingers and toes, which is the most common severe side effect of the existing product. One of the key trials Millennium submitted to the FDA showed it could reduce the rate of moderate to severe peripheral neuropathy from 16 percent to 6 percent by putting patients on the new subcutaneous form. By offering a version that’s equally effective, yet more convenient and tolerable, Millennium is hoping to neutralize one of the advantages that South San Francisco-based Onyx Pharmaceuticals (NASDAQ: ONXX) is playing up for its competing proteosome inhibitor, carfilzomib, that’s being reviewed by the FDA.

“Considering this new subcutaneous route of administration for Velcade is important for our patients, including those with poor vein access and those with pre-existing peripheral neuropathy or a high risk of developing peripheral neuropathy,” said Noopur Raje, director of the Center for Multiple Myeloma at Massachusetts General Hospital Cancer Center, in a Millennium statement. “It’s important to have a range of treatment options to provide the best possible care to each individual patient.”

The Millennium drug was approved by the FDA in 2003. It generated $1.4 billion in worldwide sales in 2009, and is on pace to eclipse $3 billion by 2015, according to BCC Research. About 20,000 people are diagnosed with myeloma each year in the U.S., and 10,000 die from it annually, according to the American Cancer Society. For more background on how the new version of Velcade could change the multiple myeloma landscape, see the FDA approval preview story I ran here last Friday.

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