T-20 approved in Europe
On 28 May the European Medicines Evaluation Agency approved T-20 (enfuvirtide, Fuzeon) for use in Europe. T-20 is the first fusion inhibitor to be approved and was developed jointly by Roche and Trimeris.
The indication is for the fairly wordy “use in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes, protease inhibitors, non-nucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens. In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. Where available, resistance testing may be appropriate.”
Supply issues may limit initial access to T-20.
EMEA European Public Assessment Reports
Roche press release
Enfuvirtide (T-20): predicting success and modelling survival benefits
Results from the T-20 registrational studies (TORO 1 and 2) have been reported in recent issues of HTB [April 2003 and others] and European approval of this new drug is welcomed. While resistance testing is not necessary for T-20 itself, it is critical in choice of background regimen.
As with other new drugs, for optimal benefit, guidelines recommend using at least one-two other drugs to which the patient is sensitive. Use of T-20 as ‘virtual monotherapy’ with probably limit duration of benefit to 6-12 months, and result in cross-resistance to T-1249, the next fusion inhibitor in the pipeline. In practice, this implies using T-20 earlier in treatment failure, at least by third line.
Other physicians are hoping to delay use of T-20 until availability of new agents such as tipranavir, or other investigational drugs, become available in trials or expanded access. An accurate timeline for access, and adequate supplies once available, are still disappointingly unreliable for new drugs.