Navigation Links
Positive CHMP Opinion for JAVLOR(R) in Metastatic Treatment of Bladder Cancer After Failure of a Prior Platinum-Containing Regimen
Date:6/26/2009

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 http://www.pierre-fabre.com.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... ... , ... Coast Dental has a new way to help parents keep their ... dentist Yvonne Dorrian, DMD, is hosting a free seminar on Friday, February 19 from ... at 1207 North Peachtree Parkway in Peachtree City. Dr. Dorrian will have healthy snacks, ...
(Date:2/8/2016)... Dallas, Texas (PRWEB) , ... February 08, 2016 , ... The Valentine’s Season is famous ... family members and significant others that they are loved. This year, for more than ... much they cost - just won't be enough to remind them of the lives they’ve ...
(Date:2/8/2016)... ... 2016 , ... Brenton Engineering , powered by Pro ... wrapped products at WestPack 2015, February 9-11, in Anaheim, California. This new solution ... or fully-automatic case packing with a small footprint, rugged, highly flexible, and cost-effective ...
(Date:2/8/2016)... ... 2016 , ... Tingley Rubber Corporation , a leading ... range of unique and advantaged protective solutions to a growing and dynamic ... customer service and marketing support. A new distribution center in Brampton, Ontario will ...
(Date:2/8/2016)... ... February 08, 2016 , ... The Bell ... selected the latest beneficiary of their ongoing community enrichment program. The current campaign ... area schools. Donations are now being accepted at: http://www.angelsanddoves.com/donate.html . , Angels ...
Breaking Medicine News(10 mins):
(Date:2/8/2016)... Feb. 8, 2016 ... of the "Label-Free Detection Market by ... 2020" report to their offering. ... addition of the "Label-Free Detection Market ... to 2020" report to their offering. ...
(Date:2/8/2016)... , Feb. 8, 2016  Unilife Corporation ("Unilife" or "Company") ... of injectable drug delivery systems, today announced that it will ... ended December 31, 2015 after market close on February 9, ... conference call to discuss these financial results.    ... --> About Unilife Corporation ...
(Date:2/8/2016)... Calif. , Feb. 8, 2016  Sangamo ... in therapeutic genome editing, announced that the U.S. ... Company,s Investigational New Drug (IND) application for SB-318, ... life-long therapy for Mucopolysaccharidosis Type I (MPS I). ... enables Sangamo to initiate a Phase 1/2 clinical ...
Breaking Medicine Technology: