Product
Istodax
Approval Date
November 5, 2009
Release Date
January 2010
Company
Gloucester Pharmaceuticals
Class
Histone deacetylase (HDAC) inhibitor
Indication
Cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy
Active Ingredient
Romidepsin
Agency Roster
In-house
Marketing Strategy/Execution
Istodax won US clearance in November for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior therapy. Gloucester has anticipated seeking approval next year for Istodax for peripheral T-cell lymphoma (PTCL), a larger market.
The aquisition of Celgene over Gloucester could leverage its marketing infrastructure to sell Istodax. Istodax poses a competitive threat for Allos Therapeutics’ newly approved Folotyn that could become more imposing with Celgene’s marketing muscle behind it. The attainment of Gloucester by Celgene introduces a deeper-pocket competitor into the field and could make Istodax a more viable threat.
Physician Outlook
Istodax is the second histone deacetylase (HDAC) inhibitor to be approved for cutaneous T-cell lymphoma after Zolinza (vorinostat, Merck). Its initial approval is as second- or later-line therapy in a rare (but hard-to-treat) disease. It is considered reasonably well tolerated, with the common toxicities (most notably, nausea, fatigue, and myelosuppression) of other therapies for hematologic malignancies. In the long run, it has promise as a therapy for more common malignancies such as B-cell lymphomas, as it has shown synergy with a variety of other therapies in preclinical studies — including the CD-20 inhibiting antibodies such as Rituxan (rituximab, Genentech) that are a mainstay of the treatment of lymphoma.
—Michael Galvin, Ph.D., Vice President, Research & Consulting, GfK Healthcare
Also in the Pipeline (courtesy of Adis R&D Insight)
No competitor compounds in phase III or pre-registration, US.
Recent MM&M Coverage
Company News: Celgene, Glouceser Pharmaceuticals, Watson Pharmaceuticals and Takeda
Professional Marketing Briefs
Pharmacology
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Clinical Trials
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Adverse Reactions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Adults
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Children
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Contraindications
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Precautions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Interactions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
