Gloucester Gears Up for FDA Panel Vote on Lymphoma Drug

9/2/09Follow @xconomy

[See update at 3:35 pm Eastern with FDA panel vote in favor.]

You can bet that the people who just put $29 million into Gloucester Pharmaceuticals a few days ago will be watching very closely today for signs they got their money’s worth.

The Cambridge, MA-based biotech company will try to make its case today at a public hearing of an FDA advisory panel that will recommend whether the drug should be made available on the U.S. market. Gloucester, which raised money last week, is seeking FDA clearance to start selling romidepsin (Istodax) for people with relapsed forms of a lymphoma that affects the skin—cutaneous T-cell lymphoma.

Gloucester is basing its application on a pair of mid-stage clinical trials of 167 patients that found that about 40 percent had their tumors completely or partially shrink after getting intravenous infusions of romidepsin. The most common side effects were nausea, infections, and anemia, according to company documents filed with the FDA. If the drug can win clearance from the FDA, it will be a new option for about 1,500 people in the U.S. who get diagnosed with cutaneous T-cell lymphoma each year.

Romidepsin is a member of a class of drugs known as histone deacetylase inhibitors. These drugs have been around a long time and have traditionally been used in neurological conditions: only relatively recently have they been considered potential cancer treatments. Merck developed the first drug in this class for cancer, when it won FDA approval in October 2006 for vorinostat (Zolinza), also for cutaneous T-cell lymphoma. Zolinza generated just $9 million in sales in the first six months of this year, so Gloucester has to be hopeful that it can enlarge the market.

“Romidepsin offers an important additional therapeutic option for the treatment of patients with cutaneous T-cell lymphoma,” Gloucester said in its briefing document filed with the FDA.

The FDA’s staff, according to its briefing documents for the panel, plans to ask the panel whether the evidence is persuasive enough for market approval, particularly since the studies weren’t designed so that some patients were randomly assigned to get another treatment for comparison’s sake.

The last question in the FDA’s briefing document is the one that investors will focus on the most: Is the risk/benefit ratio of romidepsin favorable? If the FDA advisory panel says it is, then Gloucester will likely get the official green light from the FDA, and the venture investors could find their new shares of Gloucester to be worth quite a bit more than they are today.

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