Last week, Millennium Pharmaceuticals (NASDAQ:MLNM) announced that it had submitted a supplemental New Drug Application (sNDA) with the FDA to expand the use of lead drug Velcade to patients with multiple myeloma.

Velcade has been a staple targeted therapy for treating multiple myeloma since its FDA approval in 2003. The problem for Millennium and worldwide marketing partner Johnson & Johnson (NYSE:JNJ) is that other targeted therapies, like Celgene's (NYSE:CELG) Revlimid and Thalomid, have been competing quite effectively for market share against Velcade.

Millennium's sNDA label expansion asks for Velcade to be used as a treatment for front-line multiple myeloma. Currently, Velcade is only approved as a second-line multiple myeloma drug for patients who have failed other therapies.

The use of any pharmaceutical drug is driven by the clinical trial data it produces. More so than in other indications, doctors will use anti-cancer drugs like Velcade off-label prior to FDA regulatory approval if data shows that they might be effective in a particular non-approved indication or stage of cancer.

Sales of Velcade have already been on an upswing in the third quarter, thanks to strong clinical trial results in early-stage multiple myeloma.

U.S. Net Velcade Sales

Quarter-Over-Quarter Growth

Q3 07

$70 million


Q2 07

$63 million


Q1 07

$59 million


Q4 06

$56 million


Millennium requested a priority review with the FDA for the Velcade sNDA. If granted, this will shorten the FDA review of the Velcade marketing application from 10 months down to six months. Because of the severity of multiple myeloma, expect Millennium to receive this priority review and for Velcade to be approved in front-line multiple myeloma around June.

By the time the FDA makes its decision on the Velcade label expansion, doctor treatment practices and the compendiums they use will already be aware of the Velcade data that came out at ASH earlier in the year. With the Velcade data so well-known beforehand, the importance of the FDA labeling decision will be reduced next year, but will still help Millennium market Velcade against its rivals.

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Fool contributor Brian Lawler does not own shares of any company mentioned in this article. Johnson & Johnson is an active Income Investor pick. The Fool has an A+ disclosure policy.