There are two drugs that have been recommended for approval. One is ONTAK for Cutaneous T-Cell Lymphoma (for advanced patients) and the other is for Panretin (for Kaposi's Sarcoma).
The label issue is probably most important for Panretin. The topical treatment reduced the size or height of a significant number of lesions, but generally did not "cure" the patient. Moreover, LGND did not have data on internal lesions. Consequently, the advisory committee voted 7-1 for approval, but as a "second line" treatment. Other systemic treatments have been used for KS, but Panretin will be the first topical treatment approved for the disease. LGND would like to see the drug used as a "first line" treatment, which would address a larger target population.
Once the drug is approved, MDs can use it as they see fit. Thus, even if the label says approved for second line treatment, it could be used as a first line treatment. Since most patients with KS are also taking a complex regimen of oral medications, LGND sales force could emphasize that Panretin is an easy to use topical treatment that is not systemically absorbed.
In any event, the rumor is that the label will be silent on the first line / second line issue, and therefore it is like to be used more as a first line treatment. |
