The CHMP has issued a positive opinion recommending EU marketing authorisation for Javlor from Laboratoires Pierre Fabre.
The drug has been recommended for approval 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).
The positive opinion was based on two phase II study results and a phase III randomised study conducted in the indication of metastatic treatment of bladder cancer after failure of a prior platinum-containing regimen.
If a marketing authorization is granted, Javlor will become the first monotherapy approved in Europe for this indication.
In Europe there are an estimated 100,000 new cases of bladder cancer and 50,000 deaths annually, many of which are related to the use of tobacco products.
Jean-Pierre Garnier, CEO of Pierre Fabre SA, stated: "The favourable opinion of the CHMP for Javlor 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."