Gloucester Pharma Wins FDA Approval of Drug for Rare Skin Cancer

11/5/09Follow @xconomy

Gloucester Pharmaceuticals has won clearance to start selling its first cancer drug in the U.S.

The Cambridge, MA-based biotech company said today it has gotten the green light from the FDA to start marketing its romidepsin treatment, under the brand name Istodax, for patients with a rare malignancy of the skin known as cutaneous T-cell lymphoma. The drug is expected to be commercially available starting in January, the company said in a statement.

The news comes as little surprise since Gloucester won a unanimous recommendation in early September from an advisory panel to the FDA. Gloucester built its application to the FDA around a pair of mid-stage clinical trials of 167 patients in which about 40 percent experience a reduction in tumor size after getting intravenous infusions of romidepsin. Nausea, fatigue, infections, and vomiting were the most common side effects, and were mostly mild to moderate in severity.

The company looked like such a sure bet that less than one month before it made its pitch to the FDA panel, it raised $29 million from Novo A/S, Apple Tree Partners, ProQuest Investments, Prospect Venture Partners, and Rho Ventures.

Romidepsin is a member of a class of drugs known as histone deacetylase inhibitors. These treatments have been around a long time and have traditionally been used in neurological conditions: only relatively recently have they been considered potential cancer treatments, as I described in a preview story of the FDA panel review back in September. Merck introduced the first drug in this class for cancer, after 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. The patient population with this condition is a small one—the disease affects about 1,500 people each year in the U.S.

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