The Committee for Medicinal Products for Human Use ( CHMP ), the scientific advisory committee of the European Medicines Agency ( EMEA ), has issued a positive opinion supporting approval and is recommending to grant marketing authorisation for Javlor ( Vinflunine ) as monotherapy in metastatic treatment of bladder cancer ( advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen ).

CHMP has issued a positive opinion based on two phase II study results and on the only phase III randomized study ever conducted in the indication of metastatic treatment of bladder cancer after failure of a prior Platinum-containing regimen.

When the EMEA will grant the marketing authorization, Javlor will become the first monotherapy approved in Europe for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior Platinum-containing regimen.

In Europe the burden of bladder cancer is significative with an estimated 100.000 new cases and 50.000 deaths annually, most of cases are related to the use of tobacco products.

Discovered by scientists at the Pierre Fabre Research Center, Vinflunine is a new bi-fluorinated MTI ( microtubule inhibitor ) obtained by chemistry exploiting the reactivity of Vinca scaffold in superacidic media. Such strategy, finalized in collaboration with experts at the University of Poitiers ( France ), enabled the selective introduction of two fluorine atoms in a part of that structure previously inaccessible by classic chemistry, thereby leading to the first bi-fluorinated Vinca alkaloid.
Besides its original structure, Javlor exhibits unique pharmacological properties and is also devoid of any unpredictable major toxicity and does not induce cumulative toxicity.
Its every 3 weeks administration enables convenient hospital treatment on an out patient basis ( a 20 minutes infusion without any IV premedication ).

Source: Laboratoires Pierre Fabre, 2009

XagenaMedicine2009


Link: Xapedia - Medical Encyclopedia