Navigation Links
Positive CHMP Opinion for JAVLOR(R) in Metastatic Treatment of Bladder Cancer After Failure of a Prior Platinum-Containing Regimen

CASTRES, France, June 26 /PRNewswire/ -- Laboratoires Pierre Fabre announce today 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(R) 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(R) 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(R) 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(R) 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(R) represents one of the leading products of their pipeline and these positive results reward their important efforts in oncology research.

About JAVLOR(R) (vinflunine):

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(R) 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).

JAVLOR(R) 25 mg/ml solution for infusion has been approved as monotherapy 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.

About Laboratoires Pierre Fabre

Pierre Fabre group, France's second biggest independent pharmaceutical laboratory, achieved a turnover of 1.75 billion euros in 2008. Approximatively 10,000 people including 1,400 in the research sector, are employed.

Its therapeutical areas are ethical products, healthcare products and dermocosmetics with the brands Avene, Ducray, A Derma, Galenic, Klorane and Rene Furterer. In 2008, Pierre Fabre Medicament dedicated 33% of its annual turnover to R&D in five main therapeutic directions: oncology, the Central Nervous System, cardiology, internal medicine /urology and dermatology.

To learn more about Pierre Fabre, please refer to

SOURCE Pierre Fabre SA
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. AKELA Pharma Inc. announces positive results for the extension part of its Phase IIb Fentanyl TAIFUN(R) trial
2. UCLA/RAND study shows that many children of HIV-positive parents are not in their custody
3. Blue Cross and Blue Shield of Florida Reports Eighteenth Consecutive Year of Positive Performance
4. Nutrition model stresses positive experience of eating
5. Ultrasound plus mammography finds more cancers, but increases false positives
6. Oncolytics Biotech Inc. reports positive interim results of UK phase Ia/Ib trials
7. PEAK Surgical Announces Positive Surgical Incision Wound Healing Results With the PEAK PlasmaBlade(TM)
8. Facet Solutions AFRS(TM) Implant Demonstrates Positive Clinical Results After One Year Follow Up
9. Evotec Reports Positive Top-Line Results in Phase II Study With EVT 201 in Elderly Insomniacs With Daytime Sleepiness
10. A low prevalence of H pylori in HIV-positive patients
11. Drug Company-Funded Asthma Drug Studies More Positive
Post Your Comments:
(Date:6/27/2016)... ... June 27, 2016 , ... A revolution is underway. ... transport experience for the millions of people who require these medical transport services ... industry through the use of technology. Now, SmartEMS has put forth an industry-changing ...
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A Forever Recovery, a ... and World’s Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is ... to some of the world’s leading providers of cereal and other breakfast foods. Its ...
(Date:6/26/2016)... Charlotte, NC (PRWEB) , ... June 26, 2016 , ... Brent Kasmer, a legally blind ... able to be personalized through a fitness app. The fitness app plans to fix the ... solutions currently only offer a one size fits all type program , They ...
(Date:6/25/2016)... ... ... Austin residents seeking Mohs surgery services, can now turn to Dr. Jessica ... Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to include Mohs ... Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn Goldstein, ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , the largest ... as the Medical Director of its new Mesquite-Samuell Farm facility. , “We are ... Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 Roche (SIX: ... 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) assay ... sepsis or septic shock. With this clearance, Roche is ... a fully integrated solution for sepsis risk assessment and ... with bacterial infection and PCT levels in blood can ...
(Date:6/23/2016)... , June 23, 2016 , ... Thursday, July 7, 2016 , , , , LOCATION: , ... , , , , EXPERT PANELISTS:  , , , Frost ... Industry Analyst, Christi Bird; Senior Industry Analyst, Divyaa Ravishankar and Unmesh ... The global pharmaceutical industry is witnessing an exceptional era. Several ...
(Date:6/23/2016)... , June 23, 2016 The vast ... an outpatient dialysis facility.  Treatments are usually 3 times ... hours per visit, including travel time, equipment preparation and ... patient, but especially grueling for patients who are elderly ... a skilled nursing and rehabilitation centers for some duration ...
Breaking Medicine Technology: