Laboratoires Pierre Fabre announced that 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 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, where the expectation is important for both oncologists and patients. 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.
Jean-Pierre Garnier, chief executive officer of Pierre Fabre SA, stated, "The favourable opinion of the CHMP for Javlor confirms the therapeutic interest of our anticancer product, strengthened by the clinical data of our file. Again, it rewards the quality of work done by our colleagues dedicated to R&D. Javlor will introduce innovative therapy to physicians and patients in an area considered as an unmet medical need."
This approval is a significant milestone for Laboratoires Pierre Fabre as Javlor represents one of the leading products of their pipeline and these positive results reward their important efforts in oncology research.
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.
Pierre Fabre group, France's second biggest independent pharmaceutical laboratory, achieved a turnover of 1.75 billion euros in 2008.