The US Food and Drug Administration (FDA) has given Gloucester Pharmaceuticals (GP), a 6-year-old Cambridge bio-technology start-up approval for marketing its first drug in the United States, which will be available for some patients in January.

Romidepsin (Istodax) has been approved for treating cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy for the rare skin cancer roughly that affects 20,000 people in the United States, which in turn affects the immune system.

In 2004, GP licensed Istodax’s technology from Japan’s Fujisawa Pharmaceutical Company Ltd. and since the company comprises of only a small staff, it mostly uses outside consultants for its clinical development.

Company officials were in talks with larger drug firms for forming a potential partnership to sell Istodax, but raising $29-million in venture capital recently, from a consortium of investors, they may market the drug themselves.

Ontak and Targretin manufactured by Eisai Inc. and Vorinostat by pharmaceutical giant Merck & Co. are three drugs already marketing for treating CTCL, which is a form of non-Hodgkin’s lymphoma. Drugs for treating other types of cancer are also prescribed for treating CTCL in many patients.

Common adverse reactions to the drug, include nausea, fatigue, vomiting, neutropenia, and lymphopenia. Thrombocytopenia, leukopenia, foetal harm, anorexia, and infections are some of the additional side effects.

According to GP, hematological parameters must be monitored in patients taking romidepsin, with dosages modified as necessary. As well, it should not be given with strong or potent CYP3A4 inducers and should be administered cautiously with P-glycoprotein inhibitors.

Romidepsin also reduces the effectiveness of estrogen-containing contraceptives and should not be taken by pregnant women.