Laboratoires Pierre’ Javlor Receives Positive Opinion From CHMP

CHMP has issued a positive opinion supporting Laboratoires Pierre’ approval for Javlor. Also, it is recommending to grant marketing authorisation as monotherapy in metastatic treatment of bladder cancer.

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

Jean-Pierre Garnier, CEO of Pierre Fabre, said: “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.